We have been engaged by our client to recruit for their Lead Quality Assurance Engineer position. Our client is a leading medical device company located in Minneapolis . This Lead Quality Assurance Engineer position is responsible for the management and compliance of the Quality Assurance function as well as the supervision of the associates within that group . Ideal candidates will have 5+ years of experience in medical device manufacturing quality assurance engineering supervision , including th orough working knowledge of cGMP , FDA QSR, and ISO 13485 . Local candidates only as the company will not provide relocation assistance.
- Complaint and CARIPAR System Management.
- Responsible for the Material Review Board (MRB).
- Responsible for the equipment calibration program.
- Develop new product inspection and testing procedures.
- Develop improved inspection and test methods.
- Responsible for managing the sterilization process.
- Responsible for keeping the controlled environment areas conforming to required standards.
- Assist with other projects as requested by Manager.
- Bachelor’s degree with technical focus (ME preferred).
- 5+ years medical manufacturing quality assurance engineering supervision.
- Thorough working knowledge of cGMP , FDA QSR, and ISO 13485 .
- Excellent team working skills, and the ability to work well with cross functional team along with good record/documentation management skills is a must .
- Intermediate to advanced skills with Microsoft Office .
- Excellent verbal and written technical communication skills. Ability to work professionally with customers .
- Experience in quality assurance position including medical device sterilization is preferred.
- Experience in cellular manufacturing (Lean, One-piece flow) is preferred .