Manufacturing Engineer - Medical Device Job at Virtue America, New Hampshire

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  • Virtue America
  • New Hampshire

Job Description

Job Title: Manufacturing Engineer - Medical Devices

Roles & Responsibilities:

  • Implement risk management activities as per ISO 14971 .
  • Ensure compliance with ISO 13485 and FDA 21 CFR 820 .
  • Perform PFMEA to identify and mitigate process risks.
  • Execute validation activities: IQ, OQ, PQ .
  • Support TMV (Test Method Validation) and define CTQ (Critical to Quality) parameters.
  • Maintain QMS documentation and support audits.
  • Drive CAPA, root cause analysis, and continuous improvement.

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