Software Quality Lead - Belgaum - Persolkelly India

    Persolkelly India
    Persolkelly India Belgaum

    5 days ago

    Full time
    Description

    Key Responsibilities

    • Provide lifecycle software quality oversight for Class I and Class II medical device software products
    • Ensure adherence to applicable regulations and standards including IEC 62304, FDA 21 CFR 820, and EU MDR
    • Act as a core project team member, delivering end-to-end cross-functional software lifecycle guidance and quality oversight
    • Review and ensure quality integration across all software lifecycle deliverables including requirements, risk analysis, design, development, documentation, integration, testing, verification, validation, and release
    • Oversee software milestone and gate reviews as defined by the product development process
    • Lead Quality Element Teams supporting software development initiatives
    • Collaborate closely with Regulatory teams on strategy development and execution across the complete software lifecycle
    • Support internal, external, and regulatory audits as required
    • Drive continuous improvement initiatives across software processes and Quality Management Systems
    • Lead implementation and maintenance of software-related certifications such as ISO 27001, Hitrust, and EuroPriSe
    • Support GxP validation activities and software supplier audits
    • Manage nonconformance handling, deviation management, and CAPA processes to ensure timely and compliant corrective and preventive actions

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