The Supplier Quality Engineer (Lead) will drive end-to-end execution of APQP and Process Validation activities across multiple suppliers and

change projects. This role will ensure alignment across stakeholders and timely delivery of APQP milestones and validation deliverables

(IQ/OQ/PQ/TMV) in compliance with quality and regulatory requirements.

Key Responsibilities

Lead endtoend APQP and Process Validation strategies across suppliers and manufacturing sites in compliance with ISO 13485 and FDA QSR

Define and govern APQP and validation roadmaps, ensuring alignment with NPI, design transfer, and regulatory requirements

Act as the final quality authority for APQP, PPAP, and process validation decisions (IQ/OQ/PQ/TMV)

Review and approve validation master plans, protocols, reports and PPAP submissions

Ensure consistent execution and quality of risk management tools (DFMEA, PFMEA, Control Plans) per ISO 14971





Oversee supplier and internal process readiness, capability, and compliance prior to commercialization

Proactively manage program risks, escalations, and crossfunctional alignment with R&D;, Manufacturing, Regulatory, and Operations

Drive continuous improvement, standardization, and audit readiness across APQP and validation processes

Required Skills & Experience

5 to 10 years in Supplier Quality / Manufacturing Quality

Strong expertise in APQP, PPAP, and Process Validation (IQ/OQ/PQ)

Experience in medical device industry

Robust understanding of design transfer and change control (SICR/ECN/ECO)

Proven experience managing global supplier quality programs

Excellent stakeholder management and leadership skills

📌 Medical Devices (Pune)
🏢 Tata Elxsi
📍 Pune