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Quality Engineer

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Title: Quality Engineer

Location: Milpitas, CA

ISO 13485, Supplier Quality, NC/CAPA, Purchasing Control, 21 CFR 820, Part or Component Qualification, Equipment Verification & Validation activities

Essential Skills:

  • Knowledge of Supplier Quality Related activities
  • Exposure to ISO 13485 / 21 CFR 820 / Purchasing Control
  • Equipment Verification/ Validation
  • Part/Component Qualification

Supplier Audit

Desirable Skills:

  • 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

Title: Quality Engineer

Location: Milpitas, CA

ISO 13485, Supplier Quality, NC/CAPA, Purchasing Control, 21 CFR 820, Part or Component Qualification, Equipment Verification & Validation activities

Essential Skills:

  • Knowledge of Supplier Quality Related activities
  • Exposure to ISO 13485 / 21 CFR 820 / Purchasing Control
  • Equipment Verification/ Validation
  • Part/Component Qualification

Supplier Audit

Desirable Skills:

  • 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