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
