Supplier Quality Engineer

Supplier Quality Engineer: 4 to 8 yrs with Mechanical Engineering

Location: Chakan, Pune

Key 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, NCR,  and root cause methodologies.

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.

Required Skills & Experience

4+ years of Supplier Quality Engineering experience in Medical Devices or other regulated industries.

Hands-on experience with APQP, PPAP/SPPA, PFMEA, Control Plans, MSA, and Process Validation.

Strong knowledge of CAPA, SCAR, NCR, 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.