Senior Design Quality Engineer - India - SMC Squared India

    SMC Squared India
    SMC Squared India India

    3 days ago

    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 Files (DHF), technical documentation, and compliance records.
    • Support audits, gap closure, and remediation activities.

    Cross‐Functional Collaboration

    • Work closely with R&D, systems engineering, manufacturing, and regulatory teams.
    • Participate in design reviews and risk‐management activities.

    Project Execution

    • Deliver weekly progress updates, meet time‐bound review milestones, and support complete design‐control remediation.

    Ideal Candidate Profile

    • 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.

    Additional Expectations

    • 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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