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 Xray/DXR systems, ensuring regulatory compliance, robust documentation, and successful verification & validation execution. The role requires strong expertise in FDAregulated medical devices and the ability to manage endtoend designcontrol 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 Files (DHF), technical documentation, and compliance records.
- Support audits, gap closure, and remediation activities.
CrossFunctional Collaboration
- Work closely with R&D, systems engineering, manufacturing, and regulatory teams.
- Participate in design reviews and riskmanagement activities.
Project Execution
- Deliver weekly progress updates, meet timebound review milestones, and support complete designcontrol remediation.
Ideal Candidate Profile
- 1012 years of handson experience in design quality within FDAclass medicaldevice companies.
- Strong understanding of FDA QSR (21 CFR 820), ISO 13485, risk management (ISO 14971), and medicaldevice QMS.
- Proven experience managing design controls for complex electromechanical systems (preferably imaging/Xray).
- Ability to interpret standards, drive compliance, and manage documentation at a high level of accuracy.
Additional Expectations
- Strong analytical and problemsolving abilities.
- Excellent communication and stakeholdermanagement skills.
- Ability to work independently in a fastpaced, regulated engineering environment.
