Medical Device Engineer (Supplier Quality Engineer), California

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.