What are the responsibilities and job description for the Medical Device Quality Assurance Specialist position at Trelleborg Group?
Trelleborg Medical Solutions seeks a highly skilled Quality Assurance Specialist to join their team. In this role, you will be responsible for planning and coordinating quality assurance activities for medical device manufacturing through the design and development phases.
You will collaborate with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards.
Your responsibilities will include:
- Developing and executing equipment, software, test method, and/or process validation strategies in conjunction with the NPD team
- Performing risk management by identifying, estimating, evaluating, controlling, and monitoring risk using tools such as Process Failure Modes and Effects Analysis (pFMEA)
- Authoring or approving protocols and reports for Equipment Qualification (IQ/EQ), Software Validation (SV), Test Method Validation (TMV), and Process Validation (OQ/PQ)
- Reviewing and evaluating specifications, drawings, quality agreements, customer documentation, and other documents to support NPD projects
You will also plan, coordinate, and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised products, develop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specifications.
