Software Quality Engineer
Full-time
GeneDx
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.
Vacancy posted 1 day ago
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