genedx · Remote
Summary The Software Quality Engineer, IVD Quality supports the development, implementation, and maintenance of software-specific QMS processes, including Software Development Life Cycle (SDLC), Software Risk Management, and Cybersecurity, for GeneDx’s IVD and digital products. The role reports to the Director, IVD Regulatory and Quality and works in close partnership with senior members of the IVD Quality team. Serving as the Quality representative on software development and bioinformatics teams, the Software Quality Engineer provides Quality review, guidance, and process support to ensure that software engineering activities and supporting technical documentation meet established QMS, regulatory, and standards requirements (e.g., IEC 62304 and ISO 62366). Job Responsibilities Execute assigned software-development Quality activities and support the build-out of associated SDLC QMS processes. Provide Quality review and process oversight for software design-control activities, including software requirements, architecture documentation, code-review records, and verification and validation documentation, to support compliance and audit readiness. Participate in the development and review of Design and Development File documentation throughout the product lifecycle. Serve as the Quality representative for software risk-management activities, providing guidance and review throughout the software lifecycle. Provide Quality support for validation of non-product software tools used in operations, product testing, and the quality system. Support the investigation and resolution of software-related nonconformances, deviations, and CAPAs. Provide Quality input on cybersecurity-related design-control, risk-management, vulnerability-management, and post-market activities to support alignment with applicable FDA cybersecurity guidance and established QMS requirements. Support internal and external audits by pr …truncated… I-REMOTE Pay Transparency, Budgeted Range $111,249 — $12…
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