Medical Device Design QA Engineer

Boston, MA

Industry: Medical Device Job Number: 134153

Medical Device Design QA Engineer

Project Description:

Our client is a medical device company that develops, manufactures and markets systems for the treatment of end-stage renal disease, acute kidney failure and fluid overload. They are currently seeking a Design Quality Assurance Engineer to help manage the Shelf-Life program from a Quality perspective.

  Day to Day Responsibilities:

The consultant will support the Product Development and Sustaining Engineering teams and play a key role in the Design Control process. This role will apply knowledge of Design Control principles and quality engineering techniques to positively influence new product development efforts, including those for design verification, validation, specification development, and risk management. They will need to have knowledge of shelf-life requirements for protocols and procedures. This consultant will be performing Shelf-Life/Stability  Studies on  the client’ s legacy products in order to create/improve protocols  procedures for future products. They should understand what the shelf-life requirements  are under multiple standards  and what components are needed in order for protocols and procedures to comply with these standards. It would be a huge plus if this person had packaging or labeling experience in an implantables or a disposables environment.  They will also be assisting with CAPA investigations to ensure corrections and/or corrective actions for identified nonconformances are implemented. Experience investigating CAPA’ s is a huge plus.

Required Skills:
  • Medical Device
  • Quality Assurance
  • Design Control
    • CFR Part 820.30
  • Shelf-Life/Stability
  • CAPA Investigation

Desired Skills:
  • Packaging/Labeling in Disposables or Implantables Environment

Job Type: Contract 

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