Supplier Quality Engineer

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. 8+ years of Supplier Quality experience in the Medical Device industry Strong knowledge of quality systems, supplier quality processes, and regulatory requirements.

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