Job Title: Quality Engineer

Job Description

Responsible for supporting operations by managing and prioritizing customer-related Engineering Change Orders (ECOs), corrective actions, Material Review Boards (MRBs), Return Material Authorizations (RMAs), Certificates of Conformance, problem-solving, and other related deliverables to drive continual improvement of production processes.

Responsibilities

• Work cooperatively with all employees.
• Develop, maintain, organize, and update inspection plans and methods to achieve new or changing quality requirements and standards.
• Document known/repeat quality issues to ensure best practices are implemented.
• Review and approve production-released Certificates of Conformance.
• Drive continual improvement regarding procedures, workflow, process optimization, compliance to standards, and ensure product quality.
• Investigate and determine the root cause of quality issues and assist production and other personnel with the MRB, RMA, and Corrective Action processes.
• Manage quality-related items for production-released products for existing customers.
• Initiate and manage Engineering changes and implement effective solutions to permanently address production-related issues.
• Act as a liaison between Engineering, Operations, and customers.
• Provide support to the Sustaining Quality Engineer - Operations.
• Support the operations team by providing quality insight and direction on quality-related questions and issues.
• Perform other tasks as assigned by the supervisor.

Essential Skills

• Quality engineering
• CAPA (Corrective and Preventive Actions)
• Root cause analysis
• Day-to-day problem solving
• Guidance and expertise on quality-related issues
• Management of Engineering changes (ECOs)
• Reviewing Certificates of Conformance
• Reviewing First Article Inspections (FAIs)
• Experience with medical devices

Additional Skills & Qualifications

• Bachelor’s degree in quality or equivalent experience
• Preferred three years of experience in quality with a minimum of one year in plastic injection molding
• Excellent interpersonal, communication, and project management skills
• Effective business correspondence and reporting
• Working knowledge of Microsoft Office and business operating systems
• Ability to make timely decisions, prioritize, influence, and support production and quality employees
• In-depth knowledge and understanding of contract manufacturing processes
• Knowledge of print reading, including GD&T
• Knowledge of inspection methods and measuring equipment such as CMMs, Vision systems, and validation protocols
• Ability to perform daily tasks safely and work independently with limited supervision
• Effective application of problem-solving techniques
• Ability to work with customers, vendors, and other departments
• Ability to manage multiple priorities

Work Environment

This is a non-smoking, climate-controlled, professional manufacturing facility. The manufacturing environment may be subject to airborne contaminants and chemical odors as would be customary in a manufacturing facility. Possible exposure to heat, noise, dust, dirt, oil, and waste. Walking and stair climbing are required within the office/shop areas. Physical requirements include sitting, standing, turning the head and torso, reaching, grasping, bending, and flexing the arms, legs, wrists, and fingers. Must have correctable eyesight and good depth perception. Must be able to walk, sit, and occasionally climb and balance. Must be able to prioritize multiple tasks and complete them in a timely manner, and make decisions with limited supervision.