Katalyst CRO

Medical Device Engineer (Supplier Quality Engineer)

Milpitas, CA, US

28 days ago
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Summary

Roles & Responsibilities

  • ISO 13485, Supplier Quality, NC/CAPA, Purchasing Control, 21 CFR 820, Part or Component Qualification, Equipment Verification & Validation activities.
  • Knowledge of Supplier Quality Related activities.
  • Exposure to ISO 13485 / 21 CFR 820 / Purchasing Control.
  • Equipment Verification/ Validation.
  • Part/Component Qualification.
  • Supplier Audit.
  • 10 + years of proven experience required (including 4+ years of medical devices domain & Supplier management experience preferred).
  • Experience with relevant Supplier Quality requirements is required.
  • Management of complete supplier Quality lifecycle.
  • Supplier Audit.
  • Part / Component Qualification.
  • Verification of Verification & Validation activities (hands on experience on IQ/OQ/PQ activities required).
  • Review & approval of supplier Documentations.
  • Supplier Site visits as and when required.
  • Supplier NC/CAPA lifecycle Management.
  • Weekly/Monthly Project progress dashboard generations.
  • Supplier related Risk Management.

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