Lead Quality Assurance Engineer - Medical Devices (869)
Finnesse Partners LLC - Minneapolis, MN

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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.

Responsibilities:
  • 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.
Qualifications:
  • 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 .