- Lead Design Controls activities across planning, execution, transfer, and closure.
- Ensure product documentation fully meets FDA QSR and ISO 13485 requirements.
- 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.
- Maintain and update Design History Files (DHF), technical documentation, and compliance records.
- Support audits, gap closure, and remediation activities.
- Work closely with R&D, systems engineering, manufacturing, and regulatory teams.
- Participate in design reviews and risk‐management activities.
- Deliver weekly progress updates, meet time‐bound review milestones, and support complete design‐control remediation.
- 10–12 years of hands‐on experience in design quality within FDA‐class medical‐device companies.
- Strong understanding of FDA QSR (21 CFR 820), ISO 13485, risk management (ISO 14971), and medical‐device QMS.
- Proven experience managing design controls for complex electro‐mechanical systems (preferably imaging/X‐ray).
- Ability to interpret standards, drive compliance, and manage documentation at a high level of accuracy.
- Strong analytical and problem‐solving abilities.
- Excellent communication and stakeholder‐management skills.
- Ability to work independently in a fast‐paced, regulated engineering environment.
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Senior Design Quality Engineer - India - SMC Squared India
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
Verification & Validation
Documentation & Compliance
Cross‐Functional Collaboration
Project Execution
Ideal Candidate Profile
Additional Expectations
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Quality Engineer
Only for registered members India
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Quality Engineer
Only for registered members India
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Quality Engineer
Only for registered members India
-
Quality Engineer
Only for registered members India
-
Quality Engineering
Only for registered members India
-
Quality Engineer
Full time confidential- India
-
Quality Engineer
Only for registered members India
-
Quality Engineer
Only for registered members India
-
Quality Assurance Engineer
Full time Only for registered members India
-
Quality Assurance Engineer
Only for registered members India
-
Industrial Quality Engineer
Only for registered members India
-
Quality Engineering Manager
Only for registered members India
-
Quality Test Engineer
Only for registered members India
-
Engineer Quality Outsource
Full time confidential- India
-
Quality Engineering Analyst
Only for registered members India
-
Quality Engineer/ Supervisor
Only for registered members India
-
Quality Assurance Engineering
Only for registered members India
-
Quality Assurance Engineer
Only for registered members India
-
Quality Engineering Manager
Only for registered members India
-
Quality Assurance Engineer
BITA- India
-
Quality Assurance Engineer
TRDFIN Support Services Pvt Ltd- India