Senior Design Quality Engineer

Position

Senior Design Quality Engineer

Location

Pune, India – Onsite (5 days/week)

Role Summary

The Senior Design Quality Engineer will lead Design Controls and Design Assurance activities for X‑ray/DXR systems, ensuring regulatory compliance, robust documentation, and successful verification & validation execution. The role requires strong expertise in FDA‑regulated medical devices and the ability to manage end‑to‑end design‑control lifecycle deliverables.

Key Responsibilities

Design Controls & Quality Assurance

• Lead Design Controls activities across planning, execution, transfer, and closure.
• Ensure product documentation fully meets FDA QSR and ISO 13485 requirements.

Verification & Validation

• Develop, review, and execute test cases and V&V protocols across multiple electromechanical subsystem...