Software Quality Engineer

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.