<p style="text-align: center;"><strong><u>Actalent is currently hiring &quot;Quality control technician&quot; in the</u></strong></p><p style="text-align: center;"><strong><u>Houston,Texas area</u></strong></p><p><br></p><p><strong>Job Description:</strong></p><p>Performs Quality Control assays for product release of cell therapy products and Stability Studies. Maintain data and follow cGMP regulations including writing deviations and other Quality documentation. Skill set includes (but is not limited to) working knowledge of Immunofluorescence, Sample Handling and Flow Cytometry.</p><p><br></p><p>• Performs Quality Control (QC) biological/cell based testing of Cell Therapy release and stability samples during 3rd shift. Typical test methods performed include flow cytometry based assays, but analyst may also perform proliferation, ELISA, cell counts (manual and automated), and immunofluorescence microscopy/spectroscopy assays.</p><p>• Actively participates in support of Cell Therapy technology transfer activities and validation of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols.</p><p>• Performs general lab and equipment maintenance duties.</p><p>• Performs other duties as assigned</p><p><br></p><p><strong>Qualifications:</strong></p><p>Bachelor&#39;s Degree in Scientific Discipline required</p><p><br></p><p>Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:</p><p>Medical, dental &amp; vision</p><p>Critical Illness, Accident, and Hospital</p><p>401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available</p><p>Life Insurance (Voluntary Life &amp; AD&amp;D for the employee and dependents)</p><p>Short and long-term disability</p><p>Health Spending Account (HSA)</p><p>Transportation benefits</p><p>Employee Assistance Program</p><p><br></p><p style="text-align: center;"><strong><u>If you are interested kindly give me a call on (210) 893 2401</u></strong></p><h1><br></h1>

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Quality Control Technician

<h1><strong>Job Title: Quality Control Technician</strong></h1><p><br></p><h2>Job Description</h2><p>As a Quality Control Technician, you will perform essential environmental monitoring tasks, which include maintaining laboratory supplies and equipment, supporting investigations for environmental excursions, and executing aseptic process validations. You will also be involved in quality control biological and cell-based testing of Cell Therapy release and stability samples during the 2nd shift, utilizing various test methods such as flow cytometry, ELISA, and immunofluorescence microscopy. This role is crucial for maintaining the cleanrooms for commercial manufacturing and environmental monitoring performance qualifications.</p><p><br></p><h2>Responsibilities</h2><ul><li>Perform environmental monitoring, requiring level 3 gowning qualification and extended hours in the cleanroom.</li><li>Assist with the maintenance of laboratory/media supplies and equipment.</li><li>Support investigations for environmental excursions and assist in revising standard operational procedures, trend reports, deviations, and corrective actions.</li><li>Perform water sampling and gas testing.</li><li>Execute aseptic process validations, EM performance qualifications, and gowning qualifications.</li><li>Inspect aseptic process qualification units.</li><li>Conduct Quality Control (QC) biological/cell-based testing of Cell Therapy release and stability samples during the 3rd shift.</li><li>Participate in Cell Therapy technology transfer activities and validation of analytical methods.</li><li>Perform general lab and equipment maintenance duties.</li><li>Perform other duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor&#39;s Degree in a Scientific Discipline.</li><li>3-5 years of experience in a lab setting, preferably an environmental lab.</li><li>Level 3 gowning qualification.</li><li>Knowledge in Chemistry, GMP, Biology, and Microbiology.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience with flow cytometry based assays, proliferation, ELISA, cell counts (manual and automated), and immunofluorescence microscopy/spectroscopy assays.</li><li>Ability to support technology transfer activities and validation of analytical methods.</li><li>Proficiency in generating method SOPs and executing validation protocols.</li></ul><h2>Work Environment</h2><p>The position operates on a 2nd shift schedule, Wednesday through Saturday from 2PM to 12AM. However, candidates must be able to train on the 1st shift from 8:00 am to 5:00 pm for the first few weeks. The role involves working within cleanrooms, requiring level 3 gowning and adherence to strict cleanliness and safety protocols.</p>

<h1><strong>Job Title: Quality Control Technician </strong></h1><h1><strong>Pay: $20-$22/hr </strong></h1><p><br></p><h2>Job Description</h2><p>The Quality Control Chemist performs qualitative and quantitative testing of raw materials, intermediates, and finished products, as well as other samples for the purposes of quality control, product development, and regulatory conformance.</p><p><br></p><h2>Responsibilities</h2><ul><li>Analyze raw materials, intermediates, and finished products using Symrise, FCC, USP, and AOAC wet chemical and instrumental testing methods.</li><li>Perform microbiological testing as trained and required.</li><li>Provide first-line operation and day-to-day instrument and data system maintenance and calibration.</li><li>Validate test instruments and methods as required.</li><li>Perform project analysis in support of QA, QC, Divisional, and Regulatory requirements.</li><li>Assist other departments and members of the lab in their requests for analytical testing and results.</li><li>Conform to documented roles and responsibilities for this position.</li><li>Maintain timely and complete test method certification for this position.</li><li>Complete all related quality testing and quality process responsibilities assigned by the Supervisor.</li></ul><h2>Essential Skills</h2><ul><li>Expertise in wet chemistry, GMP, and microbiology.</li><li>Understanding of quality systems such as GLP, SQF, ISO-9001, and HACCP.</li><li>Proficiency in laboratory quality control and assurance practices.</li><li>Experience with SAP is preferred.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>BS or BA in Chemistry, Food Science, Biology, or a related field with Chemistry coursework.</li><li>If lacking a degree, 3-5 years of experience in food quality is required.</li></ul><h2>Work Environment</h2><p>The position is in a laboratory environment. It is a third shift position with a flexible start time between 9 PM and 7:30 AM (e.g., could work 9 PM-5:30 AM or 11 PM-7:30 AM). Training will be provided for 1 week on the first shift (8 AM-4:30 PM) and then 1 month on the second shift (2 PM-10:30 PM).</p>

<h1 style="font-weight: 700;">Job Title: Quality Control Technician</h1><br><h2>Job Description</h2><p>Perform quality control testing in the QC Testing Laboratory according to approved SOPs and in compliance with cGMP regulations to ensure consistent production of products and support ongoing stability studies. Understand proper operation of all instrumentation and equipment within the laboratory and perform required maintenance, clean benchtops, hoods, and laboratories, and dispose of biohazardous waste. Organize and handle testing samples and maintain testing inventory. Assist with the maintenance of the equipment qualification and calibration program and upkeep of the equipment database. Assist the QA/QC Manager with review and filing of calibration certificates, out of tolerance reports, deviations, and SCARs as necessary. Assist with the development and implementation of company SOPs as assigned. Perform document control and training activities as assigned. Complete cGMP documentation accurately, in accordance with standard operating procedures, and in a timely manner. Work independently to accomplish given tasks within given timelines. Multitask and adjust to changing priorities. Report any deviations or nonconformities immediately to a Manager or Director. Perform other duties as assigned.</p><br><h2>Responsibilities</h2><ul><li>Perform quality control testing in the QC Testing Laboratory according to approved SOPs and in compliance with cGMP regulations.</li><li>Understand proper operation of all instrumentation and equipment within the laboratory.</li><li>Perform required maintenance, clean benchtops, hoods, and laboratories, and dispose of biohazardous waste.</li><li>Organize and handle testing samples and maintain testing inventory.</li><li>Assist with the maintenance of the equipment qualification and calibration program.</li><li>Upkeep the equipment database.</li><li>Assist with the review and filing of calibration certificates, out of tolerance reports, deviations, and SCARs.</li><li>Assist with the development and implementation of company SOPs.</li><li>Perform document control and training activities.</li><li>Complete cGMP documentation accurately and in a timely manner.</li><li>Work independently to accomplish tasks within given timelines.</li><li>Multitask and adjust to changing priorities.</li><li>Report any deviations or nonconformities immediately to a Manager or Director.</li><li>Perform other duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Quality control testing</li><li>GMP compliance</li><li>Laboratory instrumentation and equipment operation</li><li>Documentation skills</li><li>Independent working ability</li><li>Multitasking and adaptability</li><li>Communication and organizational skills</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Associate’s Degree in related field or equivalent work experience</li><li>6 months to 1 or more years of previous related experience</li><li>Prior experience with 21 CFR 820 is a plus</li><li>Ability to work efficiently under pressure and within deadlines</li></ul><h2>Work Environment</h2><p>1st shift: Monday - Friday 8:00am - 4:30pm. Opportunity to grow from within. Breakfast provided every Friday. Potential for raise after the contract period (not guaranteed). Summer cookouts/ice cream socials. Small company feel but backed by a large corporation ensuring strong job security. Not micromanaged.</p><br>

<h1><strong>Job Title: Quality Control Technician</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a Quality Control Technician to support a DoD customer in Falls Church, VA. This position is responsible for checking the quality of all receiving and outgoing material and products, as well as overseeing production procedures.</p><p><br></p><h2>Responsibilities</h2><ul><li>Perform receiving, in-process, and final inspection on all materials, detail components, hardware, and assemblies to ensure product compliance to all customer purchase order, engineering, IPC Standards, and quality requirements.</li><li>Interpret customer specifications, purchase orders, and blueprints to determine part conformity requirements.</li><li>Approve or reject raw materials with respect to quality standards and record supplier performance, ensuring product complies with customer requirements.</li><li>Familiar with First Articles in accordance with AS9102 requirements.</li><li>Record, document, and manage all non-conforming material following established procedures.</li><li>Assist in determining root cause(s) of nonconformances and determining effective corrective actions to prevent recurrence.</li></ul><h2>Essential Skills</h2><ul><li>Quality control</li><li>Inspection</li><li>IPC Standards 610, ISO 9100</li><li>Mechanical and electrical aspect measurements</li><li>Use of inspection tools such as micrometer, oscilloscope, and multimeter</li><li>Manufacturing engineering</li><li>Root cause analysis</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>2 years of experience in manufacturing with knowledge of manufacturing practices, procedures, inspection methodologies, and techniques in an ISO 9001 or AS9100 QMS environment.</li><li>IPC trained or certified.</li><li>Experience with AS9102 First Article Inspection Reports as required per the AS9102 standard and specific customer requirements.</li><li>Must be a U.S. Person.</li><li>Military and Aerospace is a plus.</li></ul><h2>Work Environment</h2><p>This role requires 100% onsite presence, and the candidate will work closely with the client reviewing the product line.</p>

<p><strong>Job Title: </strong>Quality Control Technician</p><p><br></p><p><strong><u>Job Description </u></strong></p><p><em>We are seeking a diligent and detail-oriented Quality Control Technician to join our quality team. The successful candidate will be responsible for performing quality control checks on the production line, ensuring the highest standards are met.</em></p><ul><li>Perform quality control checks on the production line</li><li>Conduct basic testing on products including salt, acid, viscosity, and moisture</li><li>Check Critical Control Points including metal detector and x-ray machine</li><li>Perform pre-operation inspections</li><li>Conduct microbiological and allergen swabbing</li></ul><p><strong><u>Qualifications </u></strong></p><ul><li>High School Diploma minimum, Associates Degree or Bacheror Degree preferred</li><li>Experience within the food manufacturing industry; quality assurance or quality control preferred </li><li>Knowledge of GMP (Good Manufacturing Practices)</li><li>Familiarity with HACCP (Hazard Analysis Critical Control Point) and PCQI (Preventive Controls Qualified Individual)</li></ul>

<h1 style="font-weight: 700;">Job Title: Quality Control Technician</h1><br><h2>Job Description</h2><p>This role involves performing quality inspections on finished goods, conducting audits, using a Quality Management System (QMS) and various digital platforms to maintain quality and compliance, along with additional duties as assigned.</p><br><h2>Responsibilities</h2><ul><li>Perform quality inspections on finished goods.</li><li>Conduct audits to ensure compliance with standards.</li><li>Utilize QMS and various digital platforms to maintain quality and compliance.</li><li>Assist in the development and implementation of quality assurance procedures.</li><li>Collaborate with the manufacturing team to address and resolve quality issues.</li><li>Prepare and maintain accurate documentation related to quality control activities.</li></ul><h2>Essential Skills</h2><ul><li>Quality control</li><li>Chemistry</li><li>Laboratory experience</li><li>Manufacturing process knowledge</li><li>Quality inspection</li><li>Associate&#39;s degree in the Sciences preferred</li><li>Previous experience in Quality Control and Inspection</li><li>Statistical process control</li><li>Biology</li><li>Quality assurance</li><li>Audit experience</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in insulation/panel manufacturing</li><li>Knowledge of mathematics and statistical process control</li><li>Experience in compliance</li><li>Experience in QC lab</li></ul><h2>Work Environment</h2><p>The work schedule is Monday through Friday with a 6am start time and variable end times. Candidates should expect overtime and occasional weekend work. The environment is clean and safety-focused. The position reports to the Plant Manager within a small plant focused on manufacturing insulation and panels. The company offers a broad range of insulated metal wall, roof, and deck systems, including various finishes, colors, and related accessories.</p><br>

<h1 style="font-weight: 700;">Job Title: Quality Control Technician</h1><br><h2>Job Description</h2><p>Responsible for the qualification and release testing of all immunologic reagents (antigens and antisera) produced at the laboratory.</p><br><h2>Responsibilities</h2><ul><li>Test and characterize reference standards for antigens and antisera.</li><li>Maintain stocks of reference standards and re-qualify standards as needed.</li><li>Qualify each new lot of antigen or antiserum to verify that it meets the standard requirements.</li><li>Perform validations of tests used in the SPF flock-monitoring program.</li><li>Generate Standard Operating Procedures (SOPs) and related documents associated with these tasks.</li><li>Assist in projects related to maintenance and improvement of quality control in the laboratory at the request of the management.</li><li>Perform all other related duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Experience with at least one of these tests: AGP, IFA, PCR, AJHI, MFIA, tissue culture, or cell culture</li><li>Pipetting</li><li>Sterile technique</li><li>Assay testing</li><li>PCR</li><li>ELISA (enzyme-linked immunosorbent assay)</li><li>Bioassays</li><li>Quality control</li><li>Chemistry</li><li>GMP</li><li>Biology</li><li>Quality assurance</li><li>Microbiology</li><li>Sample preparation, analysis, collection</li><li>Bench testing</li><li>Media preparation</li><li>Reagent preparation</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>High School diploma or General Education Degree (GED); Associate’s degree (A.A./A.S.) in life science or related discipline preferred.</li><li>2 years related experience</li><li>An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.</li></ul><h2>Work Environment</h2><p>While performing the duties of this job, the employee is frequently exposed to chemicals and fumes. The noise level in the work environment is usually quiet. The employee is regularly required to talk, hear, sit and stand, and use fingers and hands. Specific vision abilities required by this job include close vision and the ability to adjust focus.</p><br>

<p><strong style="font-size: 20px;">Quality Control Technician  </strong></p><p><br></p><p><strong>Job Summary:</strong>  </p><p>We are seeking a meticulous and detail-oriented <strong>Quality Control Technician</strong> to join our team. This critical role involves performing final inspections on cosmetic and personal care products to ensure they meet stringent quality standards and adhere to Good Manufacturing Practices (GMP). The Quality Control Technician will play a vital role in maintaining the integrity, safety, and excellence of our products before they reach customers.</p><p><br></p><p><strong>Key Responsibilities:</strong></p><ul><li>Conduct thorough inspections of finished cosmetic and personal care products to verify compliance with quality specifications and GMP standards.</li><li>Ensure all products are accurately labeled and packaged in accordance with company policies and regulatory requirements.</li><li>Identify and document product defects, inconsistencies, or deviations from established quality standards.</li><li>Maintain detailed inspection records and reports to ensure traceability of quality findings.</li><li>Collaborate with production and quality teams to resolve identified issues and prevent recurrence.</li><li>Assist in the development, improvement, and implementation of quality control procedures.</li><li>Participate in internal audits and support external audits as required.</li><li>Ensure adherence to all safety, health, and environmental regulations.</li><li>Provide constructive feedback to drive continuous improvement in quality assurance processes.</li></ul><p><strong>Required Skills &amp; Qualifications:</strong></p><ul><li>Minimum of 1 year of experience in quality assurance/control, preferably in the cosmetic, pharmaceutical, or medical device industry.</li><li>Working knowledge of Microsoft Word, Excel, and Outlook.</li><li>Familiarity with Quality Control/Assurance practices in a cGMP environment.</li><li>Excellent attention to detail and the ability to follow written and verbal instructions precisely.</li><li>Strong organizational skills with the ability to prioritize tasks and multitask effectively.</li><li>Outstanding written and verbal communication skills.</li><li>Motivated and able to work collaboratively with others in a team setting.</li></ul><p><br></p>

Quality Control Technician / 2nd Shift

<p><strong>Description</strong></p>
					<p>Job Summary: We are seeking a meticulous and detail-oriented Quality Control Technician to join our clients team. The successful candidate will be responsible for performing final inspections on cosmetic and personal care products to ensure they meet our high-quality standards and comply with Good Manufacturing Practices (GMP). This role is critical in maintaining the integrity and safety of our products before they reach our customers.

Key Responsibilities:

Conduct final inspections of finished products to ensure they meet quality specifications and GMP standards.
Verify that all products are correctly labeled and packaged according to company and regulatory requirements.
Inspect products for defects, inconsistencies, and deviations from established quality standards.
Document inspection results and maintain accurate records of findings.
Collaborate with production and quality teams to address and resolve any quality issues identified during inspections.
Assist in the development and implementation of quality control procedures and protocols.
Participate in internal audits and support external audits as needed.
Ensure compliance with all safety, health, and environmental regulations.
Provide feedback and recommendations for continuous improvement in quality assurance processes.</p>
					<p><strong>Skills</strong></p>
					<p>Visual, quality, batch recprd, GMP, SOP, COA, Good Manufacturing Practices, Inspection, Quality Control, Quality Assurance, Quality check, Line inspection, label, caps, production, product release, verify</p>
					<p><strong>Top Skills Details</strong></p>
					<p>Visual,quality,batch recprd</p>
					<p><strong>Additional Skills &amp; Qualifications</strong></p>
					<p>•	A minimum of 1 year of experience in quality.  Experience in the cosmetic/pharmaceutical/ Med Device industry is preferred.

•	Working knowledge of Microsoft Word, Excel and Outlook.
•	Quality Control/Assurance knowledge in a cGMP environment is required.
•	Ability to prioritize, multitask and manage time well.
•	Excellent written and verbal communication skills.
•	Attention to detail.
•	Ability to follow written and verbal directions.
•	Motivated and works well with others.</p>
					<p><strong>Experience Level</strong></p>
					<p>Entry Level</p>

Quality Control Technician 2nd Shift

<h1><strong>Job Title: Quality Coordinator</strong></h1><h1><strong>Pay: $28-$32/hr based on experience </strong></h1><h1><strong>Shift: 8am-4:30pm</strong></h1><p><br></p><p><br></p><h2>Job Description</h2><p>We are seeking a dedicated Quality Coordinator to support the inventory, setup, and documentation of new equipment acquired. The role involves supporting O2 and CO2 cylinder change outs in both GMP and Non-GMP labs, conducting walkdowns, and performing gauge and equipment checks with required documentation. The Quality Coordinator will also handle manual documentation, technical documentation, and quality checks, as well as oversee on-site contractors and help track timelines.</p><p><br></p><h2>Responsibilities</h2><ul><li>Support inventory, setup, and documentation of new equipment</li><li>Assist with O2 and CO2 cylinder change outs in GMP &amp; Non-GMP labs, ensuring proper documentation in GMP logbooks</li><li>Conduct walkdowns and gauge and equipment checks with necessary documentation</li><li>Perform manual documentation, technical documentation, and quality checks</li><li>Oversee and check on-site contractors and help track timelines</li><li>Support cleaning and upkeep functions in main areas</li></ul><h2>Essential Skills</h2><ul><li>Quality check</li><li>Visual inspection</li><li>Documentation review</li><li>Quality assurance</li><li>Inspection</li><li>Facility management</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>HS Diploma (Associates or Bachelors preferred)</li><li>Prior experience in quality coordination</li><li>Experience with documentation, SOP review, and GMP protocols</li><li>Mechanically inclined</li></ul><h2>Work Environment</h2><p>The Quality Coordinator will work directly with the Facilities/Engineering manager on a small team of 4-5 members. The dress code is business casual. The work schedule is Monday to Friday from 8:00 AM to 4:30 PM, with some flexibility.</p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p><p><br></p>

Quality Coordinator

<p style="text-align: center;"><strong>We are seeking a dedicated and detail-oriented Quality Coordinator to join our quality department.</strong></p><p style="text-align: center;"><em>The ideal candidate will assist with various quality activities, including technical records management, supplier communication, and data management.</em></p><p><br></p><p><strong><u>Key Responsibilities:</u></strong></p><ul><li>Assist with all quality activities and projects as directed by the Quality Assurance Manager.</li><li>Compile and maintain technical records, product drawings, and material documentation.</li><li>Reach out to suppliers to gather necessary information and maintain it in the system.</li><li>Review customer product specifications for accuracy and compliance.</li><li>Manage data related to product information and internal processes.</li><li>Ensure products meet established quality and regulatory standards.</li><li>Support the maintenance of the ERP system with accurate and current information.</li><li>Investigate customer complaints and non-conformance issues.</li><li>Participate in internal audits and support external audits conducted by regulatory bodies.</li><li>Recommend and implement improvements to operational methods and practices.</li></ul><p><strong><u>Top 3 Must-Have Skills:</u></strong></p><ol><li><strong>Attention to Detail</strong>: The role requires meticulous attention to detail, especially when handling technical records, product documentation, and customer specifications. Ensuring accuracy and compliance is crucial.</li><li><strong>Familiarity with Medical Devices and Regulations</strong>: Knowledge of medical devices, ISO standards (such as ISO 13485 and ISO 9001), and FDA regulations is essential. Understanding compliance requirements and regulatory standards will help maintain product quality and safety.</li><li><strong>Data Management and Analysis</strong>: Strong skills in data management and analysis are necessary for maintaining accurate records in the ERP system, managing product information, and supporting quality improvement initiatives. Proficiency in Microsoft Excel and Dynamics 365 is highly beneficial.</li></ol><p><strong><u>Qualifications:</u></strong></p><ul><li><strong>Experience</strong>:<ul></ul></li><li class="ql-indent-1">Proven work experience in a Quality Assurance or Quality Control department.</li><li class="ql-indent-1">Knowledge of quality management systems and relevant standards.</li><li class="ql-indent-1">Experience with medical devices, biotechnology devices, and cleanrooms is a plus.</li><li class="ql-indent-1">Strong attention to detail and familiarity with medical devices and regulations.</li><li class="ql-indent-1">Proficiency in Microsoft Office, especially Excel, and experience with Dynamics 365.</li><li class="ql-indent-1">Knowledge of ISO 13485, ISO 9001, and FDA regulations is a plus.</li><li class="ql-indent-1">Excellent data management and analysis skills.</li><li class="ql-indent-1">Strong communication skills and ability to work closely with others.</li><li class="ql-indent-1">Ability to multitask efficiently in a desk-based role.</li><li><strong>Education</strong>:<ul></ul></li><li class="ql-indent-1">An Associate degree or equivalent work experience is preferred.</li><li class="ql-indent-1">Relevant certifications such as Quality Auditor, Quality Engineer, or Lean Six Sigma Green Belt are a plus.</li></ul><p><strong><u>Growth Opportunities:</u></strong>We value internal promotion and offer ample opportunities for career advancement. With 150 employees, we prioritize promoting from within as positions become available.</p><p><br></p><p><strong><u>Salary</u></strong>: $25 per hour</p>

<h1 style="font-weight: 700;">Job Title: Quality Documentation Specialist</h1><br><h2>Job Description</h2><p>Facilitates end-to-end management of documents, including training requirements impact assessment, reviewing document content to ensure changes follow defined processes/procedures, and effective management and implementation of related documents. Manages controlled documentation through the document lifecycle and ensures compliance with applicable procedures and regulatory requirements. Collaborates with business owners to ensure document changes and training requirements impact assessment are effectively managed to meet timelines. Delivers quality customer service and domain knowledge when working with stakeholders. Reviews documents to ensure changes are documented and justified in accordance with procedural requirements. Identifies continuous improvements to drive efficiency of the document control and training processes. Trains users on document management and training processes as required. Collects and provides data on key performance indicators, and supports additional assignments/projects as required.</p><br><h2>Responsibilities</h2><ul><li>Facilitate end-to-end management of documents, including training requirements impact assessment.</li><li>Review document content to ensure changes follow defined processes/procedures.</li><li>Manage controlled documentation through the document lifecycle and ensure compliance with applicable procedures and regulatory requirements.</li><li>Collaborate with business owners to ensure document changes and training requirements impact assessment are effectively managed to meet timelines.</li><li>Deliver quality customer service and domain knowledge when working with stakeholders.</li><li>Review documents to ensure changes are documented and justified in accordance with procedural requirements.</li><li>Identify continuous improvements to drive efficiency of the document control and training processes.</li><li>Train users on document management and training processes as required.</li><li>Collect and provide data on key performance indicators as required.</li><li>Support additional assignments/projects as required.</li></ul><h2>Essential Skills</h2><ul><li>Minimum of 2 years of experience in the biotech/pharma industry.</li><li>Minimum of 2 years of experience with EDMS (Electronic Document Management System).</li><li>Experience with GMP and document control, including performing the technical aspects of the role.</li><li>Strong organizational skills and comfort with electronic document systems.</li><li>Ability to work in a high-speed environment and manage a high volume of work.</li><li>Experience processing 40 documents in queue on a daily basis with an expectation of 6 documents per day and 100 documents per month.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Science degree (BS or AS preferred).</li><li>Experience with Veeva Vault (training provided if experience is with a different system).</li><li>Knowledge and experience with MS Word and Excel.</li><li>Experience in the pharma industry is preferred.</li></ul><h2>Work Environment</h2><p>The role requires working from home on Mondays and Fridays, with on-site presence required on Tuesdays, Wednesdays, and Thursdays.</p><br>

Quality Documentation Specialist

<h1><strong>Job Title: Quality Documentation Specialist</strong></h1><p><br></p><h2>Job Description</h2><p>Ensure quality and regulatory documentation and information is maintained throughout the three plants. Maintain and validate all quality and regulatory documentation on a daily basis to ensure everything is in order and compliant such as SDS&#39;s, product labels, FSSC information, ISO information, etc.</p><p><br></p><h2>Responsibilities</h2><ul><li>Maintain and validate all quality and regulatory documentation on a daily basis to ensure compliance.</li><li>Address quality issues and determine the root cause to provide the correct CAPA.</li><li>Respond to customer issues/complaints to resolve quality issues and investigate problems.</li><li>Plan, conduct, and correct any internal and external audits.</li><li>Maintain the entirety of the quality management system including writing, authoring, and editing SDS&#39;s, SOP&#39;s, Change Orders, Electronic documentation systems, Regulatory information, etc.</li><li>Ensure all raw material specifications and customer specifications are documented and verified through production and quality personnel.</li><li>Provide support as needed for additional laboratory testing.</li></ul><h2>Essential Skills</h2><ul><li>Strong skillset in Quality Assurance (QA)</li><li>Experience in documentation management</li><li>Knowledge of regulatory documentation and information</li><li>Proficiency with Safety Data Sheets (SDS)</li><li>Familiarity with product labels and quality documentation</li><li>Experience with audits (FSSC, SOP&#39;s, Internal/External Audits)</li><li>Ability to interact with R&amp;D, Regulatory, other Quality personnel, operations, suppliers, customers, and external auditors</li><li>Passion for quality and regulatory work</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Safety Data Sheet (SDS)</li><li>Product Labels</li><li>FSSC</li><li>ISO</li><li>Quality Control</li><li>Quality Assurance</li><li>Quality Documentation</li><li>Quality Audit</li><li>Food Safety</li><li>HACCP</li><li>CAPA</li><li>NCR</li><li>RCA</li><li>Chempax</li><li>Technical Information</li><li>Regulatory Affairs</li><li>Hazard Communication</li><li>Technical Writer</li><li>SDS Writer</li><li>Regulatory Coordinator</li><li>ISO Practitioner</li><li>FSSC Practitioner</li><li>Food Safety Coordinator</li><li>Documentation Specialist</li><li>Quality Document Coordinator</li><li>Registration Specialist</li></ul><h2>Work Environment</h2><p>This is a 1st shift, Monday through Friday role with hours from 8:00 a.m. to 4:30 p.m., with potential for overtime if the workload requires it. You will be working with every level of the organization including quality personnel, regulatory, operations/production personnel, customers, and suppliers. A significant portion of your day will be handling QA functions and managing/maintaining/updating the quality systems. You will also fill in for QA personnel when they are out and step in as needed.</p>

<h1><strong>Job Title: Quality Engineer</strong></h1><p><strong><em>For immediate consideration, please apply directly to this job posting AND email biacosta @actalentservices.com with the following:</em></strong></p><p><strong>1) Word copy of resume</strong></p><p><strong>2) 2-3 professional references</strong></p><p><strong>3) 4-5 brief bullet points highlighting technical qualifications</strong></p><p><br></p><h2>Job Description</h2><p>The Quality Operations Specialist / Quality Engineer will be responsible for ensuring compliance with quality standards and regulatory requirements in a manufacturing environment. This role involves conducting investigations, performing quality assurance tasks, and supporting the production line by addressing deviations and maintaining strict quality standards.</p><p><br></p><h2>Responsibilities</h2><ul><li>Review investigations conducted by others and handle complaints.</li><li>Conduct complex investigations using deep dive root cause analysis.</li><li>Utilize TrackWise and SAP systems for quality management.</li><li>Review and perform QA for validation and investigations.</li><li>Collaborate with the validation and project teams.</li><li>Support the complex production line, focusing on true manufacturing.</li><li>Address deviations from manufacturing processes.</li><li>Ensure compliance with QA standards and regulatory requirements.</li><li>Conduct investigations for non-conformance and utilize problem-solving tools.</li><li>Maintain strict quality standards.</li><li>Have a fundamental understanding of validation processes.</li><li>Review packages and checklists, providing the final signature.</li><li>Perform daily quality engineering work in manufacturing areas.</li><li>Monitor manufacturing process verifications to ensure compliance.</li><li>Responsible for process monitoring, labeling control, reinspection process monitoring, and sampling process for reserved samples.</li><li>Provide quality oversight on manufacturing processes to ensure compliance including data integrity.</li><li>Provide quality support for all investigations and resolution of quality issues.</li></ul><h2>Essential Skills</h2><ul><li>3+ years of experience conducting investigations for non-conformance (NC&#39;s).</li><li>Experience in root cause analysis and using tools to determine deviations or NC.</li><li>Sign off on validation protocols for IQ, OQ, PQ, CAPA, Investigations, NCMR, FDA, change control, Quality control, root cause analysis.</li><li>Experience in quality engineering, quality assurance, and validation, particularly in the medical device field.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>An engineering degree is preferred.</li><li>Experience with QA reviews, validating new equipment, and revalidation.</li><li>Familiarity with TrackWise and SAP systems.</li></ul><h2>Work Environment</h2><p>This is an on-site manufacturing role, where you will develop, manufacture, and market innovative medical products and services to the healthcare industry. The company focuses on addressing significant healthcare challenges, including opioid abuse issues, hospital-acquired malnutrition, and hazardous drug exposure. The team consists of 64 members, including technicians and supervisors. Flexibility to work outside traditional hours is required to provide support. Each Quality Engineer oversees one business unit but may support others as needed.</p>

Quality Engineer

<h1><strong>Job Title: Quality Engineer</strong></h1><p><br></p><h2>Job Description</h2><p>Currently looking for a Quality Engineer to work in the developmental stage of our product: an implantable medical device for cardiac function. Our mission is to design, develop, manufacture, and integrate MEMS (micro-electromechanical sensors) for cardiac applications to assist with long-term, home monitoring for several chronic diseases. The Quality Engineer will actively participate in project team meetings, providing status updates as needed, and will utilize QMS software and processes for product development and data management. Excellent communication skills are essential for effectively sharing engineering direction with our suppliers, customers, and within the organization. The candidate will lead problem-solving activities and root cause analysis, leading to product and process improvement opportunities.</p><p><br></p><h2>Responsibilities</h2><ul><li>Work with cross-functional teams to streamline design documentation for regulatory submissions.</li><li>Prepare quality and regulatory documentation, including design specifications, manufacturing procedures, test methods, and manufacturing drawings.</li><li>Actively collaborate with engineers in equipment assembly and execution of installation and operational qualifications.</li><li>Improve quality and characterization test reports by developing Process Flow Charts, SOPs, Component Specifications, and Work Instructions.</li><li>Perform troubleshooting and root cause analysis.</li><li>Conduct hazard and risk analysis, and prepare necessary documentation, including DFMEA, PFMEA, and Hazard Analysis Documents.</li><li>Develop test protocols and final reports within the cross-functional team, providing guidance on advanced Quality Engineering practices.</li><li>Communicate test results concisely and in a timely manner.</li><li>Authorize DHF requirement documents, verification &amp; validation plans/reports, functional verification protocols, and other risk documentation for multiple design change projects.</li><li>Document each step of the Lifecycle process, including User Requirements Specification (URS), Function Requirements Specification (FRS), System Design Specification (SDS), Traceability Matrix, Validation Plan, and Validation Summary Report.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor&#39;s degree in mechanical engineering or related field.</li><li>Hands-on experience with quality implementation and processes in medical devices (or aerospace/defense).</li><li>Experience with corrective action planning.</li><li>Ability to read design prints and understanding of ISO standards.</li><li>Knowledge of Control Plans, PPAP, RIR, DOE, GD&amp;T, failure investigation techniques, statistical quality controls, protocol and report preparation, and non-conforming product controls.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience with the FDA approval process.</li><li>Working knowledge of ERP and MRP systems for material handling and maintenance of BOMs.</li></ul><h2>Work Environment</h2><p>The work environment consists of office space with individual offices available for each employee. Additionally, there is a clean room environment on-site where the product is being manufactured.</p>

<p><strong>Job Description</strong></p><p>The Quality Engineer is responsible for ensuring that products and processes meet established quality standards and regulatory requirements. This role focuses on analyzing, improving, and maintaining quality systems, investigating quality issues, and driving continuous improvement initiatives. </p><p><br></p><p>Key Responsibilities:</p><p>Quality System Management:</p><p>Develop, implement, and maintain quality control systems and procedures.</p><p>Ensure compliance with industry standards, regulations, and company policies.</p><p>Conduct internal audits and support external audits as required.</p><p><br></p><p>Product Inspection and Testing:</p><p>Oversee and perform inspections of materials, products, and processes to ensure compliance with specifications.</p><p>Develop and implement testing protocols and quality standards.</p><p><br></p><p>Root Cause Analysis and Corrective Actions:</p><p>Investigate and resolve product quality issues by identifying root causes and implementing corrective actions.</p><p>Track and report on non-conformance issues and drive continuous improvement efforts.</p><p><br></p><p>Supplier Quality Management:</p><p>Collaborate with suppliers to ensure material and component quality meets specifications.</p><p>Conduct supplier audits and assist in supplier development initiatives.</p><p><br></p><p>Continuous Improvement:</p><p>Lead quality improvement projects using Lean, Six Sigma, or other methodologies.</p><p>Identify opportunities for process optimization to enhance efficiency and reduce defects.</p><p><br></p><p>Documentation and Reporting:</p><p>Maintain accurate records of quality control processes, audits, and test results.</p><p>Prepare quality reports and present findings to management and stakeholders and implementing corrective actions.</p><p><br></p><p><strong>Must Have</strong></p><p>• 2+ years experience as a Quality Engineer</p><p>• Bachelor&#39;s degree in Mechanical Engineering preferred</p><p>• Strong understanding of quality systems, 5S methodologies, and tools (e.g., ISO 9001, Six Sigma, Lean Manufacturing)</p><p>• ASQ CQE certification or equivalent experience</p><p>• Experience with root cause analysis and corrective action processes (e.g., 8D, Fishbone, 5-Why).</p><p>• Experience with Gage R&amp;R</p><p>• PFMEA experience</p><p>• Experience with statistical software such as SQC Pack or Minitab®</p><p>• Understanding of control plans</p><p>• Continuous Improvement exposure</p><p><br></p><p><strong>Nice to Haves</strong></p><p>Proficient in measurement, inspection and testing methods, calibration</p><p>DOD- familiarity with government contracts</p><p>Familiarity with regulatory compliance in relevant industries (e.g., FDA, AS9100, IATF 16949)</p>

<p>Are you passionate about ensuring top-notch quality in automotive parts? Join our dynamic team as a Quality Engineer, where you&#39;ll lead the charge in maintaining and improving the quality of supplier parts for new vehicle projects. Your role will be pivotal in guaranteeing that our parts meet international standards and exceed customer expectations.</p><p>Key Responsibilities:</p><ul><li>Quality Control Leadership: Spearhead quality inspection and improvement activities for supplier parts, ensuring they meet the highest standards.</li><li>Operational Excellence: Execute the Operation Plan to ensure part quality, including field claim analysis, supplier management, and part inspection.</li><li>Problem-Solving: Analyze the root causes of part issues, implement improvement activities, and lead quality meetings to drive continuous improvement.</li><li>Facility Management: Oversee quality facility and equipment management, manage investment costs, and establish supplementary investments.</li><li>Event Coordination: Prepare, consult, and coordinate external events to showcase our commitment to quality.</li><li>Project Participation: Play a crucial role in new vehicle projects by preparing for inspections, establishing quality plans, and responding to evaluations.</li></ul><p>Top Skills:</p><ul><li>Investigative Expertise: Proven experience in investigating mechanical and electrical parts, with a strong preference for automotive industry experience.</li><li>Industry Experience: At least 2 years of experience in quality engineering, mechanical engineering, or electrical engineering.</li><li>Technical Proficiency: Ability to understand drawings and specifications of electrical and mechanical systems.</li><li>Communication Skills: Excellent verbal and written communication skills, coupled with strong problem-solving abilities.</li><li>Quality Management: In-depth understanding of quality management systems.</li></ul><p>Additional Qualifications:</p><ul><li>Bachelor&#39;s degree in electrical engineering, mechanical engineering, or a related field.</li><li>Professional Experience: 2+ years of experience in quality engineering, mechanical engineering, or electrical engineering.</li><li>Automotive Expertise: Specific experience in the automotive industry is highly desirable.</li></ul><h1><br></h1>

<h1><strong>Job Title: Quality Engineer</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a Quality Engineer to provide expert technical guidance and ensure compliance with safety regulations, standards, and codes for our facilities. This role involves performing inspections, audits, and analyses, as well as reviewing hazard analyses and design documentation. The successful candidate will document issues, create mitigation plans, and develop compliance-related processes while ensuring proper training and documentation.</p><p><br></p><h2>Responsibilities</h2><ul><li>Provide expert technical guidance to ensure facilities comply with regulations, standards, and codes.</li><li>Perform inspections, audits, and analysis of island and shipside facilities.</li><li>Review hazard analyses and design documentation for compliance.</li><li>Document facilities-related issues and create mitigation and sustainment plans.</li><li>Ensure maintenance procedures are clearly documented and trained.</li><li>Develop, update, or modify facilities documentation and compliance-related processes.</li><li>Identify and assess safety critical processes.</li><li>Implement training, assessment, and audit activities for safety critical processes.</li><li>Clearly communicate progress and provide regular updates.</li><li>Encourage team members, peers, and partners to model safe behaviors at all times.</li><li>Work with the Performance Alignment team to establish, follow, or modify a framework for documentation, training, and auditing.</li></ul><h2>Essential Skills</h2><ul><li><u>Minimum 2-4 years of experience in Facilities Engineering with increasing responsibility.</u></li><li><u>Engineer in Training (EIT) or equivalent state certification/license.</u></li><li><u>Experience with design, installation, and commissioning of facilities meeting regulatory and industrial standards.</u></li><li><u>Proven knowledge of AutoCAD and MS Office.</u></li><li>Strong written and verbal communication skills; able to present complex data concisely.</li><li>Strong interpersonal skills and ability to work on a cross-functional team.</li><li>Strong attention to detail.</li><li>High degree of self-motivation and initiative with the ability to multi-task.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Familiarity with industry regulatory, compliance standards, and processes.</li><li>Florida Professional Engineer’s License.</li><li>American Society for Quality Certification.</li><li>Experience with the Performance Alignment model.</li><li>Previous experience with the cruise line industry and maritime standards.</li><li>Proficiency with DCL SMS and AMOS.</li></ul><h2>Work Environment</h2><p>This role requires participation in occasional <strong><u>2nd and 3rd shift work or off-site work.</u></strong> The work schedule is in-office Monday through Thursday, with remote work on Fridays.</p>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>Assure product quality from design through assembly operations. Provide leadership in failure analysis and corrective action to prevent defects from happening in the manufacturing and assembly operations. The Quality Engineer will also serve as a quality representative, providing input on the manufacturability and serviceability of designs. Utilizing failure and defect reports, the role will assist in making recommendations to improve quality.</p><br><h2>Responsibilities</h2><ul><li>Perform failure and defect analysis in cooperation with Engineering and Manufacturing to determine appropriate corrective actions for quality problems and follow-up to ensure these actions are implemented.</li><li>Conduct in-process audits to identify production problems before products are submitted to Final Inspection.</li><li>Plan and execute quality measures for incoming material, manufactured components, assemblies, and finished products.</li><li>Assist in establishing effective inspection sampling plans and quality audits to ensure cost-effective compliance with customer expectations and specifications.</li></ul><h2>Essential Skills</h2><ul><li>3-5 years of experience in quality engineering with a focus on manufacturing quality and process improvement.</li><li>Proficiency in PPAP, root cause analysis, and statistical process control (SPC).</li><li>Strong understanding of quality standards, quality control, and quality assurance.</li><li>Experience in conducting audits and statistical analysis.</li><li>Bachelor&#39;s degree in Engineering or a related field.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Training in SPC and other quality tools used for process improvement.</li><li>Knowledge of SCAR, CAPA, CpK, PPAP, control plans, and non-conformance management.</li></ul><h2>Work Environment</h2><p>The position is based in a clean facility and involves a mix of desk work and on-the-floor activities. The Quality Engineer will have a dedicated desk and will use various tools to manage suppliers and improve supplier performance.</p><br>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>We are looking for a Quality Engineer to support our Quality Manager and the Quality Assurance Department. The ideal candidate will be a self-starter, motivated, and capable of working with minimal supervision. They should have prior experience in the field and the ability to collaborate with diverse personalities. Strong communication skills, attention to detail, and the ability to meet deadlines are essential. The candidate must be willing to take on various responsibilities within the QA Department.</p><br><h2>Responsibilities</h2><ul><li>Address product discrepancies and quality issues.</li><li>Collaborate with engineers and manufacturing teams to resolve problems and provide quality recommendations.</li><li>Inspect and evaluate customer-returned products for defects and report findings.</li><li>Compile quality reports by collecting, analyzing, and summarizing information and trends, including failed processes, in-process rejections, and warranty returns.</li><li>Monitor and evaluate manufacturing, assembly, and testing processes.</li><li>Conduct rework and non-conforming trend analysis.</li><li>Review records for completeness, including work orders, dimensional check sheets, and test data sheets, and verify the accuracy of test results.</li><li>Develop reports for management review.</li><li>Maintain compliance with the Material Review Board process for non-conformances.</li><li>Review non-conforming material reports for trends and corrective action solutions, including supplier evaluations.</li><li>Perform quality engineering reviews of design documentation for compliance with stated requirements.</li><li>Perform other duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Experience with First Article Inspection Reports in accordance with AS9102.</li><li>Knowledge of AS9100 requirements.</li><li>Minimum of 2 years of experience as a Quality Engineer in a manufacturing environment.</li><li>Proficiency with Windows software programs, such as Word and Excel.</li><li>Strong interpersonal and written communication skills.</li><li>Ability to read and interpret documents such as safety rules, procedures, and manuals.</li><li>Highly responsive to requests with strong attention to detail and accuracy.</li><li>Flexibility to multi-task and meet deadlines in a time-sensitive environment.</li><li>Well-organized and able to work in a fast-paced manufacturing environment.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Electrical <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">background</span></span> is required.</li><li>Experience in the aerospace industry is a plus.</li><li>RF (Radio Frequency) experience is a plus.</li><li>Ability to develop effective working relationships with customers and suppliers.</li></ul><h2>Work Environment</h2><p>The work environment is fast-paced, requiring flexibility and the ability to multi-task. The role involves working in a manufacturing setting, interacting with various team members, and ensuring compliance with industry standards. Proficiency with Windows software programs, including Word and Excel, is necessary. Strong attention to detail, accuracy, and responsiveness to requests are essential.</p><br>

<p>Job Description</p><p>• Problem analysis and mistake-proofing countermeasure investigation and evaluation</p><p>• Review and evaluate process changes</p><p>• Work to resolve customer quality concerns by facilitating activity with Internal QAE, manufacturing and production engineering personnel</p><p>• Create clear quality standards and ensure their implementation [Key Quality Check Standard, Critical Process Check Standards, Daily Production and Quality Standard, QA data sheets.]</p><p>o Develop check fixtures and evaluation methods to confirm product quality.</p><p>o Ensure test methods, equipment and programming is correct.</p><p>o Assist the development of test fixtures and procedures for new programs and identify continuous improvement ideas for current and new products.</p><p>• Timely investigation and disposition of product abnormalities.</p><p>• Ensure that department reports and distribution are timely and accurate for both within and outside the department and company</p><p>• New product preparation and evaluation. (APQP and PPAP)</p><p>• Develop and maintain new product evaluation schedule to ensure compliance to SRK-OH and Customer standards</p><p>• Attend initial builds at customer line to address concerns and represent SRK-OH’s commitment to quality</p><p>• Perform periodic pro-active customer visits</p><p>• Communicate with the customer relating to quality issues</p><p>• Participate in and support QA Target Management activities</p><p><br></p><p><strong>MUST HAVE:</strong></p><p>- 3+ years practical experience in Automotive Engineering, Engineering Quality or Manufacturing Quality</p><p>- Automotive QE experience working with Ford, Nissan, or Honda Systems/Portals</p><p>- IATF 16949, PPAP, ISO9001/14001 experience</p><p>- Experience with problem solving tools including root cause analysis and statistical analytical tools</p><p><br></p><p><strong>NICE TO HAVE:</strong></p><p>- BS Degree (Engineering)</p><p>- Have worked directly with automotive OEMs</p><p>- Experience with the following: castings, rubber curing, rubber injection molding</p>

<h1><strong>Job Title: Quality Engineer</strong></h1><p><br></p><h2>Job Description</h2><p>Currently looking for an Qualiyt Engineer to work  in the developmental stage of our product: an implantable medical device for cardiac function. Our mission is to design, develop, manufacture, and integrate MEMS (micro-electromechanical sensors) for cardiac applications to assist with long-term, home monitoring for several chronic diseases. The Quality Engineer will actively participate in project team meetings, providing status updates as needed, and will utilize QMS software and processes for product development and data management. Excellent communication skills are essential for effectively sharing engineering direction with our suppliers, customers, and within the organization. The candidate will lead problem-solving activities and root cause analysis, leading to product and process improvement opportunities.</p><p><br></p><h2>Responsibilities</h2><ul><li>Work with cross-functional teams to streamline design documentation for regulatory submissions.</li><li>Prepare quality and regulatory documentation, including design specifications, manufacturing procedures, test methods, and manufacturing drawings.</li><li>Actively collaborate with engineers in equipment assembly and execution of installation and operational qualifications.</li><li>Improve quality and characterization test reports by developing Process Flow Charts, SOPs, Component Specifications, and Work Instructions.</li><li>Perform troubleshooting and root cause analysis.</li><li>Conduct hazard and risk analysis, and prepare necessary documentation, including DFMEA, PFMEA, and Hazard Analysis Documents.</li><li>Develop test protocols and final reports within the cross-functional team, providing guidance on advanced Quality Engineering practices.</li><li>Communicate test results concisely and in a timely manner.</li><li>Authorize DHF requirement documents, verification &amp; validation plans/reports, functional verification protocols, and other risk documentation for multiple design change projects.</li><li>Document each step of the Lifecycle process, including User Requirements Specification (URS), Function Requirements Specification (FRS), System Design Specification (SDS), Traceability Matrix, Validation Plan, and Validation Summary Report.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor&#39;s degree in Mechanical Engineering or related field.</li><li>Hands-on experience with quality implementation and processes in medical devices (or aerospace/defense).</li><li>Experience with corrective action planning.</li><li>Ability to read design prints and understanding of ISO standards.</li><li>Knowledge of Control Plans, PPAP, RIR, DOE, GD&amp;T, failure investigation techniques, statistical quality controls, protocol and report preparation, and non-conforming product controls.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience with the FDA approval process.</li><li>Working knowledge of ERP and MRP systems for material handling and maintenance of BOMs.</li></ul><h2>Work Environment</h2><p>The work environment consists of office space with individual offices available for each employee. Additionally, there is a clean room environment on-site where the product is being manufactured.</p>

<p>Are you passionate about ensuring top-notch quality in automotive parts? Join our dynamic team as a Quality Engineer, where you&#39;ll lead the charge in maintaining and improving the quality of supplier parts for new vehicle projects. Your role will be pivotal in guaranteeing that our parts meet international standards and exceed customer expectations.</p><p>Key Responsibilities:</p><ul><li>Quality Control Leadership:Spearhead quality inspection and improvement activities for supplier parts, ensuring they meet the highest standards.</li><li>Operational Excellence:Execute the Operation Plan to ensure part quality, including field claim analysis, supplier management, and part inspection.</li><li>Problem-Solving:Analyze the root causes of part issues, implement improvement activities, and lead quality meetings to drive continuous improvement.</li><li>Facility Management:Oversee quality facility and equipment management, manage investment costs, and establish supplementary investments.</li><li>Event Coordination:Prepare, consult, and coordinate external events to showcase our commitment to quality.</li><li>Project Participation:Play a crucial role in new vehicle projects by preparing for inspections, establishing quality plans, and responding to evaluations.</li></ul><p>Top Skills:</p><ul><li>Investigative Expertise:Proven experience in investigating mechanical and electrical parts, with a strong preference for automotive industry experience.</li><li>Industry Experience:At least 2 years of experience in quality engineering, mechanical engineering, or electrical engineering.</li><li>Technical Proficiency:Ability to understand drawings and specifications of electrical and mechanical systems.</li><li>Communication Skills:Excellent verbal and written communication skills, coupled with strong problem-solving abilities.</li><li>Quality Management:In-depth understanding of quality management systems.</li></ul><p>Additional Qualifications:</p><ul><li>Educational <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">Background</span></span>:Bachelor&#39;s degree in electrical engineering, mechanical engineering, or a related field.</li><li>Professional Experience:2+ years of experience in quality engineering, mechanical engineering, or electrical engineering.</li><li>Automotive Expertise:Specific experience in the automotive industry is highly desirable.</li></ul><h1><br></h1>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>The Quality Operations Specialist / Quality Engineer will be responsible for ensuring compliance with quality standards and regulatory requirements within the manufacturing process. This role involves conducting and reviewing investigations, handling complaints, and performing quality assurance for validation processes. The successful candidate will collaborate with various teams to support production lines and maintain strict quality standards.</p><br><h2>Responsibilities</h2><ul><li>Review investigations conducted by others and handle complaints using deep dive root cause analysis.</li><li>Utilize TrackWise and SAP systems for quality management.</li><li>Perform QA for validation and investigations.</li><li>Collaborate with the validation team and project team.</li><li>Support the complex production line, focusing on true manufacturing rather than lab work.</li><li>Address deviations from manufacturing processes.</li><li>Ensure compliance with QA standards and regulatory requirements.</li><li>Conduct investigations for non-conformance and utilize problem-solving tools.</li><li>Maintain strict quality standards and ask candidates about the standards they use.</li><li>Monitor manufacturing process verifications to ensure compliance with operating procedures and specifications.</li><li>Perform process monitoring, labeling control, reinspection process monitoring, and sampling process for reserved samples.</li><li>Provide quality oversight on manufacturing processes to ensure compliance including data integrity.</li><li>Provide quality support for all investigations and resolution of quality issues.</li></ul><h2>Essential Skills</h2><ul><li>Minimum of 3+ years of experience conducting investigations for non-conformances.</li><li>Experience performing root cause analysis and using tools to determine deviations or non-conformances.</li><li>Proficiency in quality engineering, quality assurance, and validation processes.</li><li>Experience with medical devices.</li><li>Ability to sign off on validation protocols for IQ, OQ, PQ, CAPA, investigations, NCMR, FDA, change control, and quality control.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Engineering degree.</li><li>Fundamental understanding of validation processes.</li><li>Familiarity with QA reviews, validating new equipment, and revalidation.</li></ul><h2>Work Environment</h2><p>This is an on-site manufacturing role. The company develops, manufactures, and markets innovative medical products and services to the healthcare industry. Their products offer inherent safety features to address significant healthcare challenges. The team consists of 64 people, including technicians and supervisors. The Quality Engineer must be flexible to provide support outside traditional hours (8-5). Each QE is responsible for one business unit but supports others as needed.</p><br>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>The Quality Engineer is responsible for ensuring that products and processes meet established quality standards and regulatory requirements. This role focuses on analyzing, improving, and maintaining quality systems, investigating quality issues, and driving continuous improvement initiatives.</p><br><h2>Responsibilities</h2><ul><li>Develop, implement, and maintain quality control systems and procedures.</li><li>Ensure compliance with industry standards, regulations, and company policies.</li><li>Conduct internal audits and support external audits as required.</li><li>Oversee and perform inspections of materials, products, and processes to ensure compliance with specifications.</li><li>Develop and implement testing protocols and quality standards.</li><li>Investigate and resolve product quality issues by identifying root causes and implementing corrective actions.</li><li>Document and report on non-conformance issues and drive continuous improvement efforts.</li><li>Collaborate with suppliers to ensure material and component quality meets specifications.</li><li>Conduct supplier audits and assist in supplier development initiatives.</li><li>Lead quality improvement projects using Lean, Six Sigma, or other methodologies.</li><li>Identify opportunities for process optimization to enhance efficiency and reduce defects.</li><li>Maintain accurate records of quality control processes, audits, and test results.</li><li>Prepare quality reports and present findings to management and stakeholders.</li></ul><h2>Essential Skills</h2><ul><li>2 plus years as a Quality Engineer.</li><li>Bachelor&#39;s in Engineering (or 5 plus years of Quality Engineering experience if no degree).</li><li>Strong understanding of quality systems, 5S methodologies, and tools (e.g., Six Sigma, Lean Manufacturing).</li><li>ASQ CQE certification or equivalent experience.</li><li>Experience with root cause analysis and corrective action processes (e.g., 8D, Fishbone, 5-Why).</li><li>Experience with Measurement System Analysis (MSA) and Gauge R&amp;R.</li><li>Proficiency in PFMEA.</li><li>Experience with statistical software such as SQC Pack or Minitab®.</li><li>Understanding of control plans.</li><li>Exposure to continuous improvement methodologies.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Proficient in measurement, inspection, and testing methods, calibration.</li><li>Familiarity with government contracts (DOD).</li><li>Familiarity with regulatory compliance in relevant industries (e.g., FDA, AS9100, IATF).</li><li>Experience in Supplier Quality Management.</li></ul><h2>Work Environment</h2><p>Work in a recently remodeled facility with a game room area and an extremely clean manufacturing environment. The company is dedicated to developing leading-edge products that protect against serious and potentially life-threatening impact-related injuries. The role involves in-line inspections, implementing new equipment, and quality standards for manufacturing helmets.</p><br>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>Responsible for a wide range of inspection functions supporting quality operations. This includes reviewing documents, drawings, and specifications, as well as planning to meet quality standards. You will also create manufacturing plans for production and train manufacturing teams (Inspection and Production) to understand customer requirements.</p><br><h2>Responsibilities</h2><ul><li>Perform first article inspections on machined parts using micrometers, calipers, and other measurement devices while working in compliance with AS9100 standards.</li><li>Review planning and work instructions.</li><li>Train quality and production teams to meet customer requirements.</li><li>Utilize precision measurement tools and equipment including calipers, micrometers, height gauges, hardness testers, and conductivity meters.</li><li>Familiarize with outside processing certifications.</li><li>Read and interpret Engineering drawings and models.</li><li>Use Microsoft Office efficiently.</li><li>Apply CATIA/Enovia CAD experience.</li><li>Understand basic CMM operations.</li><li>Understand basic CNC machining.</li><li>Conduct AS9100/QMS audits.</li><li>Implement Six Sigma/8D methodologies and RCCA training.</li><li>Communicate with internal customers.</li><li>Perform assembly inspections.</li><li>Conduct CMM inspections.</li><li>Approve first article inspections (FAI).</li></ul><h2>Essential Skills</h2><ul><li>Minimum of five years’ experience in Quality Aerospace/Aircraft.</li><li>Proficiency in quality engineering and quality assurance.</li><li>Experience with CATIA, blueprint reading, and AS9100 standards.</li><li>Quality inspection experience.</li><li>Proficiency in reading engineering drawings/models.</li><li>Proficiency with Microsoft Office.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Basic understanding of CMM.</li><li>Basic understanding of CNC machining.</li><li>Experience with Six Sigma/8D and RCCA training.</li><li>Familiarity with outside processing certifications.</li></ul><h2>Work Environment</h2><p>This is a full-time position with hours from Monday to Friday, 8 AM to 5 PM, in an engineering office area. The quality department is expanding, and this new role will help manage the increased workload coming into the shop.</p><br>

<h1 style="text-align: center;"><strong>Hiring for a Quality Engineer!</strong></h1><p><br></p><h2>Job Description</h2><p>The Process Quality Engineer will be responsible for ensuring that all manufacturing processes meet the stringent quality standards required for Class III medical devices. This role involves developing, implementing, and maintaining quality systems and processes to ensure compliance with regulatory requirements and industry standards. </p><p><br></p><h2>Responsibilities</h2><ul><li>Develop and implement process validation protocols and reports (IQ, OQ, PQ) to ensure manufacturing processes are capable and compliant.</li><li>Conduct root cause analysis and implement corrective and preventive actions (CAPA) to address process-related quality issues.</li><li>Collaborate with cross-functional teams, including R&amp;D, Manufacturing, and Regulatory Affairs, to ensure product quality and compliance.</li><li>Monitor and analyze process performance data to identify trends and areas for improvement.</li><li>Lead process improvement initiatives to enhance product quality, reduce waste, and increase efficiency.</li><li>Ensure compliance with FDA regulations and other applicable standards.</li><li>Participate in internal and external audits, providing necessary documentation and support.</li><li>Train and mentor production staff on quality standards and best practices.</li></ul><h2>Essential Skills</h2><ul><li>Quality engineering</li><li>Quality assurance</li><li>Supplier quality</li><li>Medical Device QE <span style="color: rgb(8, 7, 7); background-color: none;">background</span></li><li>Quality Assurance</li><li>Supplier/Manufacturing Quality Support</li><li>PPAP</li><li>Root cause analysis</li><li>Audit</li><li>Medical device</li><li>CAPA</li><li>Quality control</li><li>Quality management</li><li>ISO</li><li>PFMEA</li><li>5+ years experience</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in developing and implementing process validation protocols and reports (IQ, OQ, PQ)</li><li>Ability to conduct root cause analysis and implement corrective and preventive actions (CAPA)</li><li>Strong collaboration skills with cross-functional teams</li><li>Experience in monitoring and analyzing process performance data</li><li>Leadership in process improvement initiatives</li><li>Knowledge of FDA regulations and other applicable standards</li><li>Experience participating in internal and external audits</li><li>Ability to train and mentor production staff on quality standards and best practices</li></ul>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>As a Quality Engineer, you will oversee the monitoring of injection molding processes to ensure consistent product quality. You will implement process improvements to enhance product quality, reduce waste, and improve manufacturing efficiency. Additionally, you will analyze data on product quality and process performance, identify trends and areas for improvement, and prepare and present reports on quality metrics and performance to <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">senior</span></span> management. You will also collaborate with cross-functional teams to implement effective corrective and preventive actions.</p><br><h2>Responsibilities</h2><ul><li>Oversee the monitoring of injection molding processes to ensure consistent product quality.</li><li>Implement process improvements to enhance product quality, reduce waste, and improve manufacturing efficiency.</li><li>Analyze data on product quality and process performance to identify trends and areas for improvement.</li><li>Prepare and present reports on quality metrics and performance to <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">senior</span></span> management.</li><li>Collaborate with cross-functional teams, including production, engineering, and R&amp;D, to implement effective corrective and preventive actions.</li><li>Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure product quality and compliance.</li></ul><h2>Essential Skills</h2><ul><li>4+ years of experience in audit and medical device industry.</li><li>Strong understanding of quality assurance principles and methodologies.</li><li>Experience with FDA 21 CFR Part 11 and Part 820.</li><li>Strong attention to detail.</li><li>Experience with metrology.</li><li>Experience in process validation, quality management, quality assurance, and injection molding.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in client-facing and cross-functional roles.</li></ul><h2>Work Environment</h2><p>The work environment includes both a manufacturing floor and an office setting. It is a fast-paced and deadline-driven environment.</p><br>

<h1><strong>Job Title: Sr. Quality Engineer</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a dedicated Sr. Quality Engineer to monitor performance at our automotive facility, handle customer complaints, and maintain positive customer relations. The role includes supervising customer liaisons, managing corrective actions, maintaining databases, and leading RPN reduction activities. </p><p><br></p><h2>Responsibilities</h2><ul><li>Monitor performance to customer assembly plants, including complaint resolution and customer scorecard performance.</li><li>Maintain positive customer relations and respond to customer concerns.</li><li>Supervise customer liaisons and ensure good communication and relationships among the customer, liaisons, and our client.</li><li>Assign and approve corrective actions (Quality Bulletins, 8D&#39;s, DMN&#39;s) as appropriate.</li><li>Maintain corrective action databases including Exteriors GCAR and Our Client, and compile and submit all required corporate or customer reports.</li><li>Review and approve deviations, correlations, control plans, FMEAs, and Process Flow diagrams as required.</li><li>Lead RPN reduction activities.</li><li>Utilize AIAG &#39;Core Tools&#39;.</li><li>Fulfill Quality Engineer role for any specific programs assigned.</li></ul><h2>Essential Skills</h2><ul><li>Experience with APQP, PPAP, and statistical process control (SPC).</li><li>Competent in AIAG &#39;Core Tools&#39;.</li><li>Bachelor&#39;s degree with 4-5 years of experience.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in the automotive industry preferred.</li><li>Experience in high-volume, high-speed environments such as food and beverage is also applicable.</li></ul><h2>Work Environment</h2><p>Our client is a supplier to the automotive industry located in Nashville, IL. They manufacture liftgates, door modules, exterior fascias and trim, front-end modules, aerodynamic systems, running boards, sealing, trim, and engineered glass. </p>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>We are hiring for a Quality Engineer within an Automotive Market Quality division. This role focuses on conducting activities to support achieving department performance metrics and targets. The Quality Engineer will implement countermeasures when necessary to ensure department results.</p><br><h2>Responsibilities</h2><ul><li>Perform analysis of failed warranty parts. Subject components and vehicles to test conditions in an effort to identify failures and simulate possible causes or influences. (30%)</li><li>Identify warranty problems related to design, manufacturing, or sales/service influences, promote and carry out investigations, and determine root causes. (25%)</li><li>Perform technical writing, documentation, and reporting, and present summaries to quality management. (20%)</li><li>Communicate with suppliers, design, and service teams to appropriately support problem investigation and resolution. (15%)</li><li>Work with responsible departments and suppliers to facilitate appropriate problem containment. (5%)</li><li>Support cost recovery efforts and negotiations by meaningfully examining warranty data and associated analysis records. (5%)</li></ul><h2>Essential Skills</h2><ul><li>Bachelor&#39;s degree in electrical, electronic, electrical technology, mechanical engineering, or equivalent related work experience.</li><li>0-6 years of experience based on education.</li><li>Ability to investigate technical problems, derive conclusions from observations and data, and analytically approach root cause.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in the automotive industry, particularly with transmission, quality engineering, and quality assurance.</li><li>Co-op experience, transmission assembly, automotive repair, and automotive maintenance.</li></ul><h2>Work Environment</h2><p>This role is based in an automotive environment with a clean and quality-focused setting. The position offers a contract-to-hire opportunity for those looking to advance their career in quality engineering.</p><br>

<h1><strong>Job Title: Quality Engineer</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a dedicated Quality Engineer with a strong inspection <span style="color: rgb(8, 7, 7); background-color: none;">background</span> and experience in root cause analysis. This role involves a significant amount of documentation, reviewing certifications and drawings, and backfilling inspections when not engaged in engineering tasks.</p><p><br></p><h2>Responsibilities</h2><ul><li>Conduct audits adhering to AS9100/ISO9001 standards.</li><li>Perform PPAP (Production Part Approval Process) and First Article Inspections.</li><li>Execute Root Cause Corrective Actions.</li><li>Track quality activities within various customer portals.</li><li>Support the inspection team with gage control, and inspecting and measuring dimensions on in-process parts.</li><li>Assist with overflow of parts in production.</li><li>Maintain daily interface with outside services and customers.</li><li>Maintain records and documentation.</li><li>Read and interpret blueprints and specifications.</li></ul><h2>Essential Skills</h2><ul><li>Quality engineering experience.</li><li>Root cause analysis.</li><li>Audit experience.</li><li>Knowledge of AS9100 and ISO9001 standards.</li><li>First Article Inspection (FAI) expertise.</li><li>PPAP process knowledge.</li><li>Proficiency in reading and interpreting blueprints and specifications.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>3-5 years of work experience in a similar role.</li><li>Hands-on experience with inspection tools and measurements.</li><li>Computer skills, particularly in Microsoft Excel.</li></ul><h2>Work Environment</h2><p>The position is based in a shop floor/manufacturing environment with an extremely casual dress code. The company has less than 50 employees, offering a close-knit team atmosphere. The work hours are from 8am to 4:30pm, Monday through Friday. The role reports to the Quality Engineering Liaison and serves as a bridge between management and inspectors.</p>

<p><strong>Description</strong></p>
					<p>This position is responsible for assisting daily production, work on continuous improvement of his/her department, participating to the LEAP activities like PSM, managing the customer complaints and the CAPA/NCR linked to his/her scope of activities, assuring compliance to and providing guidance regarding interpreting governmental regulations and ISO 13485 &amp; FDA standards in link with the Manufacturing Quality Engineer activities. The Manufacturing QE acts as an Operational Lead for the QAR (Quality Representative) of his/her department.

Primary Responsibilities:
- For the Quality topics, assisting daily production and participating to achieve the APU objectives determined with the APU manager.
- Create/Maintain updated quality plans and work instructions, inspection and control plans, inspection work instruction, PFMEA,… including the respect of quality requirements and standards.
- Act as an Operational Lead with the QAR working in the same APU, which include but not limited to work with the Planner to define the inspection priority, manage the daily QAR PSM1, help to harmonize the QAR practices, escalation of issues when applicable.
- The HR activities are supervised by the QA manager, in link with the Manufacturing QE such as defining the QAR training needs, preparation of performance reviews, problem resolution.
- Identify continuous improvement opportunities and support efforts in order to implement LEAP principles throughout the organization, such as participating to PSM or LEAP workshop.
- The NCR and the CAPA investigation linked to his/her APU, with respect to the due date define and using problem solving tools when applicable, and working as part of a cross-functional team.
- Participate and be the QA lead for validation of equipment repairing with Maintenance, IT and the APU.
- Interface with client and the supplier in case of Customer complaints or supplier SCAR. (Lead)
- Transfer knowledge experience from the AO Quality Engineer when a project is mature enough to be considered as production phase.
- Contribute to the APU employee training.
- 6 sigma, statistical technics and 8D problem solving SMEs for his/her APU

Secondary Responsibilities:
- Train new employee for the Quality induction part.
- Be back up of the other Manufacturing QE
- Be the secondary backup of his/her APU AO QE.
- Perform internal or external audits
- Compile and analyze statistical data in order to assess process capabilities and control processes and conduct Process Failure Mode Effects and Analysis (PFMEA), Gauge Repeatability and Reproducibility (GR&amp;R) and Statistical Process Control (SPC) studies.</p>
					<p><strong>Skills</strong></p>
					<p> NCR, Gd&amp;t, Quality assurance, Medical device,  gauge r&amp;r, Quality engineering, Supplier quality, technical writing, work instruction, Iso 13485, blueprint reading, Corrective action plans, Quality management system</p>
					<p><strong>Top Skills Details</strong></p>
					<p>NCR,Gd&amp;t,Quality assurance,Medical device</p>
					<p><strong>Additional Skills &amp; Qualifications</strong></p>
					<p>- B.S. degree preferably in Manufacturing Engineering (or a related engineering field)
- Minimum two years relevant experience / five years for <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">senior</span></span> position
- Experience working within a CAPA program
- Experience developing manufacturing quality plans
- Experience conducting process capability, GR&amp;R, PFMEA and SPC studies
- Experience optimizing processes to achieve ongoing cost reductions
- Experience working in an ISO environment, preferably ISO 13485
- LEAN / Six Sigma training and demonstrated application
- Proficient PC skills in a Windows environment
- Effective written and verbal communication skills
- Strong interpersonal and teamwork skills</p>
					<p><strong>Experience Level</strong></p>
					<p>Entry Level</p>

<h1><strong>Job Title: Quality Engineer</strong></h1><p><br></p><h2>Job Description</h2><p>As a Quality Engineer, you will play a pivotal role in ensuring quality assurance in both the defense and commercial aspects of the company. Your role will include tasks such as maintaining QA programs, inspecting parts, analyzing and addressing non-conforming materials, determining root causes, and generating corrective action plans. You will be responsible for collecting, compiling, and reporting data based on quality KPIs and managing calibration and quality control procedures. You will also serve as the liaison between engineering and production to triage problems and proactively solve them. This role may require some travel to work with suppliers on quality-related issues.</p><h2><br></h2><h2>Essential Skills</h2><ul><li>Degree in engineering.</li><li>Minimum of 3 years’ experience in quality assurance and quality control.</li><li>Knowledge of Quality Assurance and Quality Control System procedures and techniques.</li><li>Ability to read technical drawings and interpret instructions.</li><li>Proficiency in Microsoft Suite, with an emphasis on Outlook and Excel.</li><li>Ability to maintain positive communication and working relationships with different departments and outside vendors.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Knowledge of Lean manufacturing principles.</li><li>Experience with ERP systems.</li><li>Ability to facilitate and lead small teams.</li><li>Experience in coordinating and compiling data collection.</li><li>Experience in ISO certification and audits.</li></ul>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>We are seeking a skilled Quality Engineer to lead efforts in improving Supplier Quality Reject performance. The successful candidate will participate in Quality Reviews and Powertrain Variability Reduction Team meetings to address supplier warranty concerns. They will support QR procedures, assist with non-responsive suppliers, and ensure data accuracy. Coordination of quality confirmation for suppliers with repeated containment failures and support of containment for supplier Stop Ship issues are key aspects of this role. The Quality Engineer will also work with stakeholders to report accurate root causes for Prevent the personion Closure (PAC) process and act as a liaison between Supplier Quality and manufacturing plant management, supporting Daily Plant Quality Meetings.</p><br><h2>Responsibilities</h2><ul><li>Lead efforts to improve Supplier Quality Reject performance.</li><li>Participate in Quality Reviews and Powertrain Variability Reduction Team meetings to resolve supplier warranty concerns.</li><li>Support QR procedures and assist with non-responsive suppliers.</li><li>Ensure QR/PPM data accuracy.</li><li>Coordinate quality confirmation for suppliers with repeated containment failures.</li><li>Support containment of supplier Stop Ship issues and assist with suspect material tracking.</li><li>Work with stakeholders to report accurate root causes for Prevent the personion Closure (PAC) process.</li><li>Serve as liaison between Supplier Quality and manufacturing plant management.</li><li>Support Daily Plant Quality Meetings.</li></ul><h2>Essential Skills</h2><ul><li>Supplier quality management</li><li>Root cause analysis</li><li>Containment</li><li>Quality engineering</li><li>Problem solving skills (8D/FMEA)</li><li>Automotive/powertrain experience</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in the automotive industry (from OEM or Tier Supplier)</li><li>Knowledge of powertrain, engine, and transmission systems preferred</li></ul><h2>Work Environment</h2><p>The Quality Engineer will work in a dynamic and collaborative environment, engaging with various stakeholders to ensure quality standards are met. The role involves participating in daily plant quality meetings and working closely with suppliers and manufacturing plant management. Standard office hours apply, with occasional travel to supplier sites as required.</p><br>

<h1><strong>Job Title: Quality Engineer</strong></h1><p><strong><em>For immediate consideration, please apply directly to this job posting AND email biacosta@actalentservices.com</em></strong><em> </em><strong><em>with the following: </em></strong></p><p><strong>1) Word copy of resume</strong></p><p><strong>2) 2-3 professional references</strong></p><p><strong>3) 4-5 brief bullet points highlighting technical qualifications</strong></p><p><br></p><h2>Job Description</h2><p>We are seeking a Quality Engineer with a strong experience in machining and familiarity with metallurgical concepts. The ideal candidate will have experience with NADCAP and AS9100 standards, and will be able to interface effectively with customers and suppliers. This position involves troubleshooting quality issues, working with continuous improvement and lean manufacturing principles, and ensuring quality resolutions for machining operations.</p><p><br></p><h2>Responsibilities</h2><ul><li>Interface with customers and respond to customer quality requests.</li><li>Work on quality resolutions for machining orders and adjust parameters to correct issues.</li><li>Serve as the point person for customer communication regarding quality matters.</li><li>Apply metallurgical concepts to troubleshoot and resolve quality issues related to material testing.</li><li>Participate in continuous improvement initiatives and lean manufacturing processes.</li><li>Perform inspection and testing related to machining and quality assurance.</li><li>Assist with qualification of packages and ensure proper processing through the shop.</li></ul><h2>Essential Skills</h2><ul><li>3+ years of experience as a Quality Engineer.</li><li>Experience with NADCAP and AS9100 standards.</li><li>Strong exposure to metallurgy and material properties.</li><li>Experience with continuous improvement and lean manufacturing principles.</li><li>Proficiency in machining and machine shop operations.</li><li>Excellent communication skills for interfacing with customers.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Lab experience and testing experience in a lab setting.</li><li>NADCAP certification.</li><li>Experience with dimension inspection.</li><li>Knowledge of PPAP, root cause analysis, APQP, quality management, and quality engineering.</li></ul><h2>Work Environment</h2><p>The work environment is a forging site specializing in metal fabrication with materials such as steel and aluminum. The facility is focused on expanding capabilities in aerospace manufacturing, with significant investments planned for growth over the next decade. This role offers a pathway to management within 16-24 months and includes opportunities for bonuses.</p>

<h1><strong>Job Title: Aerospace Quality Engineer -Agawam, MA</strong></h1><p><br></p><h2>Job Description</h2><p>We are seeking a dedicated Quality Engineer with a strong inspection <span style="color: rgb(8, 7, 7); background-color: none;">background</span> and experience in root cause analysis. This role involves a significant amount of documentation, reviewing certifications and drawings, and backfilling inspections when not engaged in engineering tasks.</p><p><br></p><h2>Responsibilities</h2><ul><li>Conduct audits adhering to AS9100/ISO9001 standards.</li><li>Perform PPAP (Production Part Approval Process) and First Article Inspections.</li><li>Execute Root Cause Corrective Actions.</li><li>Track quality activities within various customer portals.</li><li>Support the inspection team with gage control, and inspecting and measuring dimensions on in-process parts.</li><li>Assist with overflow of parts in production.</li><li>Maintain daily interface with outside services and customers.</li><li>Maintain records and documentation.</li><li>Read and interpret blueprints and specifications.</li></ul><h2>Essential Skills</h2><ul><li>Quality engineering experience.</li><li>Root cause analysis.</li><li>Audit experience.</li><li>Knowledge of AS9100 and ISO9001 standards.</li><li>First Article Inspection (FAI) expertise.</li><li>PPAP process knowledge.</li><li>Proficiency in reading and interpreting blueprints and specifications.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>3-5 years of work experience in a similar role.</li><li>Hands-on experience with inspection tools and measurements.</li><li>Computer skills, particularly in Microsoft Excel.</li></ul><h2>Work Environment</h2><p>The position is based in a shop floor/manufacturing environment with an extremely casual dress code. The company has less than 50 employees, offering a close-knit team atmosphere. The work hours are from 8am to 4:30pm, Monday through Friday. The role reports to the Quality Engineering Liaison and serves as a bridge between management and inspectors.</p>

<h1 style="font-weight: 700;">Job Title: Supplier Quality Engineer</h1><br><h2>Job Description</h2><p>This position involves no supervisory responsibilities and requires the ability to interact effectively with various cross-functional teams. The role demands excellent oral and written communication skills to present information and respond to questions from managers, suppliers, customers, and the public.</p><br><h2>Responsibilities</h2><ul><li>Develop and maintain an effective supplier quality system.</li><li>Ensure compliance with procedures outlined in the Supplier Quality Manual, such as ISO9001/IATF16949.</li><li>Lead supplier development activities and implement necessary changes.</li><li>Participate in supplier reviews and provide input to the Purchasing Department regarding supplier quality.</li><li>Conduct supplier quality audits in accordance with ISO9001, IATF16949, and VDA6 standards.</li><li>Ensure the reliability and accuracy of products from the supply base and address nonconforming materials promptly.</li><li>Coordinate supplier quality performance initiatives and track performance trends.</li><li>Perform quality trend analysis from the supplier base and facilitate corrective actions.</li><li>Support suppliers in developing robust processes to achieve the Zero Defect Initiative.</li><li>Provide support to customers on supply-based issues.</li></ul><h2>Essential Skills</h2><ul><li>Thorough knowledge of quality tools and APQP methods such as FMEA, Control Plan, Measurement Equipment including MSA, and PPAP.</li><li>Ability to read technical specifications and drawings.</li><li>Strong problem-solving skills and experience in continuous improvement techniques.</li><li>Proficiency in standard business applications software and specialized data analysis tools.</li><li>Six Sigma Green/Black Belt Certification.</li><li>ISO/IATF auditor certification.</li><li>2-5 years of related audit experience.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Spanish language skills.</li><li>Experience in Plastic Molding and Assembly processes.</li></ul><h2>Work Environment</h2><p>The role involves using various state-of-the-art quality tools, including PPAP, FMEA, Control Plan, and more. The work environment emphasizes continuous improvement and the use of lean manufacturing practices. There is significant interaction with cross-functional teams and suppliers. The position requires proficiency in Microsoft Excel, Word, and other standard business applications, as well as specialized data analysis tools.</p><br>

<h1><strong>Job Title: Quality Engineer</strong></h1><p><br></p><h2>Job Description</h2><p>We are looking for a Quality Engineer to support our Quality Manager and the Quality Assurance Department. The ideal candidate will be a self-starter, motivated, and capable of working with minimal supervision. They should have prior experience in the field and the ability to collaborate with diverse personalities. Strong communication skills, attention to detail, and the ability to meet deadlines are essential. The candidate must be willing to take on various responsibilities within the QA Department.</p><p><br></p><h2>Responsibilities</h2><ul><li>Address product discrepancies and quality issues.</li><li>Collaborate with engineers and manufacturing teams to resolve problems and provide quality recommendations.</li><li>Inspect and evaluate customer-returned products for defects and report findings.</li><li>Compile quality reports by collecting, analyzing, and summarizing information and trends, including failed processes, in-process rejections, and warranty returns.</li><li>Monitor and evaluate manufacturing, assembly, and testing processes.</li><li>Conduct rework and non-conforming trend analysis.</li><li>Review records for completeness, including work orders, dimensional check sheets, and test data sheets, and verify the accuracy of test results.</li><li>Develop reports for management review.</li><li>Maintain compliance with the Material Review Board process for non-conformances.</li><li>Review non-conforming material reports for trends and corrective action solutions, including supplier evaluations.</li><li>Perform quality engineering reviews of design documentation for compliance with stated requirements.</li><li>Perform other duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>Experience with First Article Inspection Reports in accordance with AS9102.</li><li>Knowledge of AS9100 requirements.</li><li>Minimum of 2 years of experience as a Quality Engineer in a manufacturing environment.</li><li>Proficiency with Windows software programs, such as Word and Excel.</li><li>Strong interpersonal and written communication skills.</li><li>Ability to read and interpret documents such as safety rules, procedures, and manuals.</li><li>Highly responsive to requests with strong attention to detail and accuracy.</li><li>Flexibility to multi-task and meet deadlines in a time-sensitive environment.</li><li>Well-organized and able to work in a fast-paced manufacturing environment.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Experience in the aerospace industry is a plus.</li><li>RF (Radio Frequency) experience is a plus.</li><li>Ability to develop effective working relationships with customers and suppliers.</li></ul><h2>Work Environment</h2><p>The work environment is fast-paced, requiring flexibility and the ability to multi-task. The role involves working in a manufacturing setting, interacting with various team members, and ensuring compliance with industry standards. Proficiency with Windows software programs, including Word and Excel, is necessary. Strong attention to detail, accuracy, and responsiveness to requests are essential.</p>

<h1 style="font-weight: 700;">Job Title: Quality Engineer</h1><br><h2>Job Description</h2><p>We are seeking a dedicated Quality Engineer with a strong inspection <span style="color: rgb(8, 7, 7); background-color: none;"><span style="color: rgb(8, 7, 7); background-color: none;">background</span></span> and experience in root cause analysis. This role involves a significant amount of documentation, reviewing certifications and drawings, and backfilling inspections when not engaged in engineering tasks.</p><br><h2>Responsibilities</h2><ul><li>Conduct audits adhering to AS9100/ISO9001 standards.</li><li>Perform PPAP (Production Part Approval Process) and First Article Inspections.</li><li>Execute Root Cause Corrective Actions.</li><li>Track quality activities within various customer portals.</li><li>Support the inspection team with gage control, and inspecting and measuring dimensions on in-process parts.</li><li>Assist with overflow of parts in production.</li><li>Maintain daily interface with outside services and customers.</li><li>Maintain records and documentation.</li><li>Read and interpret blueprints and specifications.</li></ul><h2>Essential Skills</h2><ul><li>Quality engineering experience.</li><li>Root cause analysis.</li><li>Audit experience.</li><li>Knowledge of AS9100 and ISO9001 standards.</li><li>First Article Inspection (FAI) expertise.</li><li>PPAP process knowledge.</li><li>Proficiency in reading and interpreting blueprints and specifications.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>3-5 years of work experience in a similar role.</li><li>Hands-on experience with inspection tools and measurements.</li><li>Computer skills, particularly in Microsoft Excel.</li></ul><h2>Work Environment</h2><p>The position is based in a shop floor/manufacturing environment with an extremely casual dress code. The company has less than 50 employees, offering a close-knit team atmosphere. The work hours are from 8am to 4:30pm, Monday through Friday. The role reports to the Quality Engineering Liaison and serves as a bridge between management and inspectors.</p><br>

<h1><strong>Job Title: Quality Engineer - Bristol, CT </strong></h1><p><br></p><h2>Job Description</h2><p>The Quality Engineer is responsible for developing and implementing quality strategies, policies, processes, standards, and systems for the company and its supply chain. This role ensures compliance with the Quality Management System (ISO 9001) and drives continuous improvement throughout the organization. The Quality Engineer will manage the audit program and lead a team to achieve quality management system targets for customers and business goals.</p><p><br></p><h2>Responsibilities</h2><ul><li>Develop the Management Systems strategy and management arrangements for key milestones, demonstrating solid progress against plans.</li><li>Ensure ongoing compliance with the Quality Management System (ISO 9001).</li><li>Contribute to new business initiatives and projects, reviewing and communicating the impact on Quality Management Systems.</li><li>Manage all external registration requirements and liaise with external bodies on all matters related to registration.</li><li>Implement relevant procedures described in the Quality Management System.</li><li>Ensure in-house systems and procedures are updated, revised, and modified to meet the needs of external certification bodies.</li><li>Ensure necessary systems and procedures are in place to satisfy all customer requirements and audits.</li><li>Introduce new systems and procedures where appropriate.</li><li>Train others in all aspects of the quality system and application of procedures.</li><li>Undertake regular internal and process audits of the QMS.</li><li>Ensure corrective actions are undertaken to address nonconformities found.</li><li>Verify closure of nonconformities with Certification Bodies.</li><li>Hold regular audit performance meetings with Certification Bodies.</li><li>Manage the audit nonconformity database and provide detailed analysis of nonconformities.</li><li>Develop, implement, and manage key performance indicators (KPIs) for each area of responsibility and set objectives for departments.</li><li>Report on achievement of targets and identify any actions required.</li><li>Consistently promote high standards through personal example and roll out through the team.</li><li>Communicate with personnel at all levels, internally and externally, in relation to Quality matters.</li><li>Comply with Health, Safety, and Environmental Policies.</li><li>Proactively contribute to creating a good team atmosphere.</li><li>Anticipate and overcome obstacles.</li><li>Make useful links to arrive at insightful plans and solutions.</li><li>Embrace personal challenge.</li><li>Take ownership for team cohesion and team development.</li><li>Be a self-starter, focused, motivated, and able to positively motivate others.</li><li>Follow the Group Code of Conduct and Group Compliance Policy.</li><li>Perform other related duties as assigned.</li></ul><h2>Essential Skills</h2><ul><li>High level of interpersonal skills with a customer/client focus.</li><li>Flexibility.</li><li>Excellent written, verbal, and presentation skills.</li><li>Excellent organizational and follow-up skills.</li><li>Competent in problem solving, team building, planning, and decision making.</li><li>Attention to detail.</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>High school diploma or GED diploma, Bachelor’s degree in a related field, or five years’ related experience in a manufacturing environment, or equivalent combination of education and experience.</li><li>Experience in quality assurance, quality control, procedure analysis, process improvement, internal audit, quality engineering, ISO 9001, supplier quality, quality systems management, and quality system documentation.</li><li>5-7 years of experience.</li><li>Experience writing and implementing standards/policies/procedures.</li><li>Openness to 20% travel to other facilities.</li><li>Hands-on experience with the ability to understand hands-on issues with a part/project.</li><li>Experience with internal auditing and customer-facing experience.</li><li>Manufacturing and union experience.</li><li>Root cause analysis.</li><li>Industry experience.</li><li>Exposure to managing a union environment.</li><li>Detailed understanding of ISO 9001.</li><li>Experience dealing with customers and suppliers.</li></ul>

<p><strong>Description</strong></p>
					<p>Working with suppliers on part design, defects, quality, and reporting. Candidate  needs to be process driven, hands on. Experience with design of automotive parts/vehicles is preferred. Candidate will need to be able to problem solve.
Will work with suppliers on part issues happening on the production floor. Will coordinate root cause and corrective actions.
Knowledge of Solidworks/AutoCAD. Must be able to read schematics/blue prints</p>
					<p><strong>Skills</strong></p>
					<p>Automotive,  engineer,  supplier,  continuous improvement, quality engineering, root cause analysis, supplier quality, fea analysis</p>
					<p><strong>Top Skills Details</strong></p>
					<p>Automotive, engineer, supplier, continuous improvement,quality engineering</p>
					<p><strong>Additional Skills &amp; Qualifications</strong></p>
					<p>MUST HAVE:
Degree in Mechanical, Electrical, Industrial, or Manufacturing. Working with suppliers on part defects, part design , strong interest in automotive vehicle quality,  continuous improvement. Candidate  needs to be process driven, hands on.
Knowledge of Solidworks/AutoCAD.Must be able to read schematics/blue prints.
Entry level candidates must have experience through internship/school ( Sr design project Automotive related) 
Experience with corrective actions, measuring tools, quality investigations
hands on experience through internship or projects in school- automotive/manufacturing processes</p>
					<p><strong>Experience Level</strong></p>
					<p>Entry Level</p>

<h1><strong>Job Title: Quality Engineer</strong></h1><p><strong><em>For immediate consideration, please apply directly to this job posting AND email biacosta @actalentservices.com with the following:</em></strong></p><p><strong>1) Word copy of resume</strong></p><p><strong>2) 2-3 professional references</strong></p><p><strong>3) 4-5 brief bullet points highlighting technical qualifications</strong></p><p><br></p><h2>Job Description</h2><p>Control production processes through implementation of inspection plans, failure analysis investigations, and continuous improvement activities. You will plan and conduct the analysis, inspection, design, test, and/or integration. Additionally, you will perform quality reviews of design documentation for compliance, including vendor quality manuals and company quality records. Your role will involve performing failure analysis investigations to determine improvement opportunities and directing technical and administrative workers engaged in quality assurance activities. You will also maintain a working knowledge of government and industry quality assurance codes and standards and manage both customer and supplier facing quality functions for the applicable business unit.</p><p><br></p><h2>Responsibilities</h2><ul><li>Control production processes through implementation of inspection plans, failure analysis investigations, and continuous improvement activities.</li><li>Plan and conduct the analysis, inspection, design, test, and/or integration.</li><li>Perform quality reviews of design documentation for compliance, including vendor quality manuals and company quality records.</li><li>Perform failure analysis investigations to determine improvement opportunities.</li><li>Direct technical and administrative workers engaged in quality assurance activities.</li><li>Maintain a working knowledge of government and industry quality assurance codes and standards.</li><li>Manage both customer and supplier facing quality functions for the applicable business unit.</li></ul><h2>Essential Skills</h2><ul><li>Bachelor’s Degree in Engineering</li><li>3+ years of related experience in Quality Engineering</li><li>Knowledge of ISO 9000 and AS9100 policies and procedures</li><li>Knowledge of FAA part 21 and part 145 requirements</li><li>Proficiency in failure analysis, CAPA, and Quality Engineering</li><li>Experience in Manufacturing Engineering, Validation, and Test Procedures</li><li>Expertise in Quality Control, PPAP, Corrective Action Plans, First Article Inspection</li><li>Familiarity with PFMEA, GD&amp;T, Audit, and Quality Management Systems</li><li>Strong understanding of aerospace quality standards</li></ul><h2>Additional Skills &amp; Qualifications</h2><ul><li>Excellent computer skills in a Microsoft Windows environment</li><li>Excellent communication with team and stakeholders</li></ul><h2>Work Environment</h2><p>You will be working in the Quality Department, which is led by a Director of Quality. The team consists of seven individuals (inspectors and engineers), and there is an urgent need to support the current workload. The environment is fast-paced and operates with a lean team. The company promotes from within, offers great benefits, and runs like a family-owned business, despite being part of a large organization. Leadership development opportunities and the ability to transfer to other locations are available.</p>

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