Base Salary
$111k - $123k/yr
Responsibilities
- Execute software-development quality activities and help build SDLC quality-management-system processes.
- Review and oversee software design-control documentation, including requirements, architecture, code-review records, verification, and validation evidence.
- Participate in Design and Development File documentation throughout the product lifecycle.
- Provide quality guidance for software risk management and validation of non-product software tools.
- Support investigations and resolutions for software nonconformances, deviations, and CAPAs.
- Provide cybersecurity quality input across design controls, risk management, vulnerability management, and post-market activities.
- Prepare software-related objective evidence for internal and external audits and assist with responses to findings.
- Monitor regulatory expectations, standards, and best practices and contribute to software quality-process improvements.
Requirements
- Bachelor’s or advanced degree in a relevant scientific or technical field such as Computer Science, Engineering, or Bioinformatics.
- At least 6 years of software QA experience, including at least 4 years 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 lifecycles 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 is preferred.
Benefits
- Fully remote work from a home office or other suitable remote location.
- Standard work schedule is Monday through Friday, 9 AM to 5 PM EST, with hours subject to adjustment based on business needs.
- GeneDx provides compensation and benefits aligned with local market practices and legal requirements.
- Inclusive workplace with equal employment consideration and support for professional and personal well-being.
Categories
About GeneDx
We see a world where every genetic condition is understood, and every patient receives the care they need to live their healthiest life through genomics. GeneDx combines unmatched clinical expertise, advanced technology, and the power of GeneDx Infinity™, the world’s largest rare disease genomic dataset. This unparalleled foundation powers GeneDx’s ExomeDx™ and GenomeDx™ tests – ranked #1 by expert geneticists and granted FDA Breakthrough Device Designation – enabling clinicians to deliver precise, fast, and actionable diagnoses. With over 25 years of innovation, more than 4,800 genetic diseases diagnosed, and over 1,000 scientific publications, we’re building the genomic intelligence network that’s shaping the future of precision medicine: for patients, providers, and partners alike.