Supplier Quality Engineer (Medical Devices)
- Tata Elxsi
- 7 - 14 years
- Pune
- 3 days ago
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Job Description
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
6 to 12 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
Job Classification
Industry: MiscellaneousFunctional Area / Department: Quality AssuranceRole Category: Production & ManufacturingRole: Quality EngineerEmployement Type: Full timeContact Details:
Company: Tata ElxsiLocation(s): Pune
Keyskills: PPAP APQP special process validation Process validation SPC MSA MDR Medical Devices
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