Responsibilities :
- This Co nsultant will help the team execute a developed strategy by working on the validation of deliverables and all associated documentation.
- Write, review, and execute test method and process validation strategy and related deliverables to meet quality system requirements.
Experiment tech reports, GR&R, TMV, IQ, FMEA's, etc.)
- Support the implementation of process controls.
- Review risk management documentation.
Requirements :
- BS in Engineering + years of medical device experience.
- Strong expertise with IQ / OQ / PQ. Must be familiar with medical device test method and process validation execution & strategy.
- Strong understanding of ISO and associated QMS experience.
- Injection Mounding experience.
- Experience with Keyence systems.
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This Co nsultant will help the team execute a developed strategy by working on the validation of deliverables and all associated documentation. Write, review, and execute test method and process validation strategy and related deliverables to meet quality system requirements. BS in Engineering + yea...
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