Summary :
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
