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Quality Engineer II

Looking to bring on a Quality Engineer Level II candidate into our growing organization. We are looking for someone with a Electro-Mechanical Medical Device background but open to other engineering degrees.

Responsibilities:

  • Design Input creation - Reviewing specified requirements
  • Design Output Creation and Review: Drawings, Engineering Specification review, Input for Design for Manufacturability/Design for Inspection, Receiving inspection documents
  • Associated product Reviews
  • Risk Management Plan
  • Design Verification/Validation
  • Review of Surgical Technique, Labels, and IFUs
  • Design History File Phase Gate Deliverable per Design Control Procedure
  • Quality Assurance: ensuring compliance of all the project deliverable to procedures governing the new product development process
  • Process Validation/Process Verification

Must Have:

  • 3+ years of Medical Device experience
  • Design Validation and Verification
  • Understanding of design controls
  • Must be able to work in the US without sponsorship

Sthree US is acting as an Employment Business in relation to this vacancy.