Software Quality Engineer

GeneDx is hiring a Software Quality Engineer, IVD Quality to support software-specific quality management processes for its IVD and digital products. The role provides quality oversight and guidance to software development and bioinformatics teams, supporting design controls, risk management, cybersecurity, regulatory compliance, and audit readiness.

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

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, 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
• Certified Software Quality Engineer (CSQE) preferred