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.
#LI-REMOTE
At GeneDx, we're driven by urgency and purpose: helping patients get diagnosed earlier. Our mission, to empower everyone to live their healthiest life through genomics, drives our team to make a tangible impact each day – and shapes our culture where high standards, strong teamwork, and meaningful ownership are the norm. We act with intention, support one another, and deliver work we're proud to put our names on.
Here’s what you can expect day to day:
1. Play like a champion (step up, redefine what’s possible, own it)
We bring energy, focus, and a bias for action. We step up, take initiative, and deliver on our commitments – with quality, speed, and care.
We push past the obvious. We challenge assumptions, raise the bar, and make thoughtful, decisive calls — choosing progress over perfection.
We stay curious, ask questions, and share direct feedback with respect. We adapt quickly and keep learning through collaboration and continuous improvement.
If you’re motivated by meaningful work, a fast-moving environment, and teammates who care deeply about outcomes, you’ll thrive at GeneDx.
We welcome everyone regardless of their background. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, age, and other characteristics protected by law.
GeneDx is a place where people from all backgrounds can make an impact.
All privacy policy information can be found here.
Skills Required
- Bachelor's or advanced degree in a relevant scientific or technical field such as Computer Science, Engineering, or Bioinformatics
- 6 or more years of software quality assurance experience
- 4 or more years of experience in medical device or FDA-regulated software development
- Practical experience with design controls, ISO 13485, ISO 14971, and IEC 62304
- Experience with Software as a Medical Device or medical devices containing software
- Strong understanding of design control procedures and software development life cycle processes in regulated environments
- Experience supporting regulatory submissions and audits
- Ability to manage multiple projects and priorities in a fast-paced environment
- Certified Software Quality Engineer certification
GeneDx Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GeneDx and has not been reviewed or approved by GeneDx.
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Parental & Family Support — Family-building benefits and extended paid parental leave are highlighted as standout features of the package. Feedback suggests these offerings are a notable strength for employees planning families.
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Healthcare Strength — Comprehensive medical, dental, and vision coverage with behavioral-health resources and virtual care is described as robust. Feedback suggests health coverage is often viewed favorably relative to other elements of compensation.
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Retirement Support — A 401(k) with employer match is included as part of the core offering. Feedback suggests this support enhances the perceived value of total rewards for many roles.
GeneDx Insights
What We Do
GeneDx is focused on delivering personalized, actionable insights that improve health outcomes. We sit at the intersection of diagnostics and data science, pairing decades of genomic expertise with an unmatched ability to interpret clinical data at scale. Our exome and genome testing is among the best in the industry. We expect that it will be even more advanced in the future with the help of Centrellis®, our innovative health information platform. Powered by millions of medical records, Centrellis® integrates digital tools with artificial intelligence to ingest and synthesize clinical and genomic data. As a result of our robust test menu, including our exome and genome testing, and the comprehensive insights generated by Centrellis®, we are developing a more complete understanding of complex disease than ever before. This translates to faster diagnosis, more effective treatment plans, and enhanced drug discovery. Our offerings help a whole spectrum of healthcare partners -- clinicians, researchers, health systems, pharmaceutical companies, and payors -- improve patient experiences and advance population health
