Software Quality Engineer

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 preparing software-related objective evidence and assisting with responses to findings.

• Monitor evolving regulatory expectations, standards, and best practices for software in IVDs, including FDA and international guidance; recommend updates to applicable processes and documentation.

• Contribute to continuous improvement initiatives related to software development and quality processes.

Education, Experience, and Skills

• A bachelor’s or advanced degree in a relevant scientific or technical field (e.g., Computer Science, Engineering, Bioinformatics).
• 6+ years of software QA experience, with 4+ years in medical device or FDA-regulated software development. 
• Practical experience with design controls, ISO 13485, ISO 14971, IEC 62304 regulations.
• Experience with Software as a Medical Device or medical devices containing software. Strong understanding of design control procedures and the software development lifecycle in regulated environments. 

• Experience supporting regulatory submissions and audits. 

• Ability to manage multiple projects and priorities in a fast-paced environment.

Certificates, Licenses, Registrations 

• Certified Software Quality Engineer (CSQE) preferred.

Work Environment 

• This is a fully remote position. The employee will work from a home office or other suitable remote location with reliable high-speed internet access. Work is performed in a climate-controlled environment using standard office equipment including computer, phone, and video conferencing tools. Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs.

• Standard work hours are Monday through Friday, 9 AM to 5 PM EST.

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