Supplier Quality Engineer

Responsibilities

• Partner with Development, Manufacturing, Procurement, and Suppliers to assess risks and define Critical-to-Quality (CTQ) requirements.
• Lead and execute APQP deliverables for supplier onboarding, product transfer, and change management activities.
• Review and support PFMEA, Control Plans, MSA, SPC, Process Validation, and Line Release activities.
• Support supplier qualification, supplier audits, supplier performance monitoring, and supplier corrective action programs.
• Drive disposition and resolution of supplier quality issues using CAPA, SCAR, Client, 8D, and root cause methodologies.
• Support Design Transfer and Manufacturing Transfer activities from source manufacturing sites to receiving manufacturing facilities.
• Carefully coordinate IQ/OQ/PQ, TMV, validation builds, and process readiness activities.
• Work closely with cross-functional teams to ensure compliance with quality and regulatory requirements throughout the transfer lifecycle.
• Support New Product Introduction (NPI), sustaining engineering, and manufacturing change implementation.

Requirements

• 5+ years of Supplier Quality Engineering experience in Medical Devices or other regulated industries.
• Hands-on experience with APQP, PPAP/SPPA, PFMEA, Control Plans, MSA, SPC, and Process Validation.
• Strong knowledge of CAPA, SCAR, Client, Root Cause Analysis, and Supplier Quality Systems.
• Experience supporting Manufacturing Transfer, Design Transfer, or NPI programs.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Strong communication and stakeholder management skills.