Document Control Specialist

Description

We are seeking a detail-oriented and experienced Document Control Specialist to join our team. In this role, you will be responsible for managing and maintaining quality assurance processes, including document control, corrective and preventive actions (CAPA), and Quality Management System (QMS) compliance. You will work closely with cross-functional teams to ensure that our products and processes meet the highest standards of quality and regulatory requirements. Key Responsibilities Document Control: Manage and maintain all quality documentation, including quality manuals, procedures, and plans. Ensure all documentation is accurate, complete, and compliant with regulatory standards. CAPA (Corrective and Preventive Actions): Implement and monitor CAPA processes to address non-conformances and customer complaints. Ensure the effectiveness of corrective actions through follow-up audits and reviews. Quality Management System (QMS): Manage and maintain the QMS, ensuring adherence to applicable standards and regulations. Conduct internal and external audits to ensure compliance and timely resolution of audit findings. Quality Assurance Integration: Collaborate with product development and manufacturing teams to integrate quality standards into all processes. Risk Assessments: Conduct risk assessments and failure mode effects analysis (FMEA) for new and existing products. Quality Control Methods: Develop and implement quality control methods, procedures, and performance metrics for product design and manufacturing. Problem Solving: Lead problem-solving and improvement activities to address quality issues and reduce product and process nonconformities. Process Audits: Conduct audits of design and manufacturing processes to ensure compliance with quality system requirements and identify opportunities for improvement. Data Analysis: Compile and analyze statistical data to identify and prioritize areas for quality improvement. Reporting: Prepare and present reports on product and process quality to management and customers. Training and Mentoring: Train and mentor staff on quality system requirements, quality tools, and best practices.

Skills

Document control, Quality assurance, medical device, Quality control

Top Skills Details

Document control,Quality assurance

Additional Skills & Qualifications

Education: Bachelor’s degree in Engineering, Quality Assurance, or a related field. Experience: 1-3 years of experience in quality assurance or a related role. Skills: Strong knowledge of document control processes and systems. Proficiency in CAPA processes and methodologies. Thorough understanding of Quality Management System (QMS) standards and regulations. Familiarity with product design and manufacturing processes. Proficiency in quality tools and statistical analysis. Excellent analytical and problem-solving skills. Strong communication and interpersonal skills. Ability to work collaboratively in a team environment. Preferred Qualifications Experience with ISO 13485:2016 and 21 CFR Part 820 standards. Knowledge of risk management and FMEA. Experience in conducting process audits and quality control.

Experience Level

Intermediate Level