Senior Supplier Quality Engineer

Tata Elxsi, Inc.; Pune District; On-site; INR 1,100,000 - 1,900,000; Full time

Job summary

Tata Elxsi, Inc. in Pune, India, is seeking a Senior Engineer / Specialist to drive supplier quality activities spanning APQP, process validation, and regulatory compliance for medical devices.

You will align stakeholders and deliver IQ/OQ/PQ/TMV milestones with ISO 13485 and FDA QSR requirements. The role requires hands-on leadership, deep knowledge of APQP, PPAP, and process validation, and proven experience managing global supplier quality programs.

Qualifications

• 4 to 8 years in Supplier Quality / Manufacturing Quality
• Strong expertise in APQP, PPAP, and Process Validation (IQ/OQ/PQ)
• Experience in medical device industry
• Strong understanding of design transfer and change control (SICR/ECN/ECO)
• Proven experience managing global supplier quality programs
• Excellent stakeholder management and leadership skills

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

Skills

APQP

PPAP

Process Validation

Supplier Quality

Medical Devices

Design Transfer

Change Control

SICR/ECO/ECN

Global supplier programs

Stakeholder Leadership

Job description

Senior Engineer / Specialist

Location: Pune

The Supplier Quality Engineer 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

4 to 8 years in Supplier Quality / Manufacturing Quality

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

Experience in medical device industry

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

Proven experience managing global supplier quality programs

Excellent stakeholder management and leadership skills