Software Quality Engineer
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Job Description
Software Quality Engineer supporting GeneDx’s genomic diagnostic products. Ensuring software QMS, risk management, cybersecurity, and regulatory compliance.
Responsibilities:
- Support the development, implementation, and maintenance of software-specific QMS processes, including SDLC, Software Risk Management, and Cybersecurity
- Serve as the Quality representative on software development and bioinformatics teams
- Provide Quality review, guidance, and process support for software engineering activities and technical documentation
- Execute assigned software-development Quality activities and support SDLC QMS process development
- Oversee software design-control activities, including requirements, architecture documentation, code-review records, and verification and validation documentation
- Participate in Design and Development File documentation throughout the product lifecycle
- Guide and review software risk-management activities
- Support validation of non-product software tools
- Investigate and resolve software-related nonconformances, deviations, and CAPAs
- Provide Quality input on cybersecurity design control, risk management, vulnerability management, and post-market activities
- Support internal and external audits by preparing software-related objective evidence and assisting with findings
- Monitor regulatory expectations, standards, and best practices for software in IVDs, recommending process and documentation updates
- Contribute to continuous improvement initiatives related to software development and quality processes
Requirements:
- 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
- 4+ years in medical device or FDA-regulated software development
- Practical experience with design controls, ISO 13485, ISO 14971, and 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
- Certified Software Quality Engineer (CSQE) preferred
Benefits:
- Competitive compensation and benefits reflecting local market practices and legal requirements
- Fully remote work from a home office or other suitable remote location
- Standard work schedule of Monday through Friday, 9 AM to 5 PM EST
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