Supplier Quality Engineer

Supplier Quality Engineer (SQE)

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 and responsibilities include:

• Ensuring suppliers consistently deliver quality parts, materials, and services meeting company requirements
• Evaluating and onboarding suppliers into the Approved Supplier List (ASL)
• Reviewing and approving PPAP documentation, Control Plans, Process Flow Charts, Capability Studies, DFMEA, and PFMEA
• Conducting supplier risk assessments and maintaining supplier risk profiles
• Facilitating Supplier Quality Agreements and conducting supplier audits
• Supporting Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans
• Coordinating supplier evaluation and selection activities for new suppliers and process changes
• Managing documentation within PLM systems and ensuring timely approvals and releases
• Collaborating with global quality teams on Supplier Data Review (SDR) and Supplier Owned Quality (SOQ) initiatives

Education and 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