Auditing, Design Failure Mode and Effects Analysis (DFMEA), Document Management, Documentation, Documentation Plan, Medical Equipment, Process Failure Mode and Effects Analysis (PFMEA), Process Flow, Process Validation, Product Lifecycle Management, Production Part Approval Process (PPAP), Quality Engineering, Regulatory Requirements, Risk, Risk Analysis, Risk Management, Software Testing, Systems Administration/Management, Time Management, Vendor/Supplier Evaluation, Vendor/Supplier Selection
We are seeking an experienced Supplier Quality Engineer (SQE) with a strong background in the Medical Device industry to support supplier quality, compliance, and process validation activities.
Roles & Responsibilities :- Ensure suppliers consistently deliver quality parts, materials, and services meeting company requirements
- Evaluate and onboard suppliers into the Approved Supplier List (ASL)
- Review and approve PPAP documentation, Control Plans, Process Flow Charts, Capability Studies, DFMEA, and PFMEA
- Conduct supplier risk assessments and maintain supplier risk profiles
- Facilitate Supplier Quality Agreements and conduct supplier audits
- Support Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans
- Coordinate supplier evaluation and selection activities for new suppliers and process changes
- Manage documentation within PLM systems and ensure timely approvals and releases
- Collaborate with global quality teams on Supplier Data Review (SDR) and Supplier Owned Quality (SOQ) initiatives
Education & Experience :- Bachelor's degree in Engineering, Technical, or Scientific discipline
- 8+ years of Supplier Quality experience in the Medical Device industry Strong knowledge of quality systems, supplier quality processes, and regulatory requirements
- Experience with PPAP, DFMEA, PFMEA, MSA, Risk Management, and Process Validation (IQ/OQ/PQ)
- Experience working with PLM systems and quality documentation tools
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Katalyst Healthcares & Life Sciences