Software Quality Lead

Job 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 improvem...