Job Description
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 subsystems.
Ensure traceability between design inputs, outputs, risks, and V&V results.
Documentation & Compliance
Maintain and update Design History...
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 subsystems.
Ensure traceability between design inputs, outputs, risks, and V&V results.
Documentation & Compliance
Maintain and update Design History...
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