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 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.