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← GeneDx

Software Quality Engineer

GeneDx
Location
Remote
Posted
18 days ago
Department
Enterprise Risk
What they actually want (must-haves)
  • 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, 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
Nice to have
  • Certified Software Quality Engineer (CSQE) preferred
What the job really is

The Software Quality Engineer at GeneDx will support the development and maintenance of software quality management system processes for IVD and digital products. This role involves providing quality oversight on software development activities, ensuring compliance with regulatory standards, and participating in risk management and validation processes. The engineer will also contribute to audits, monitor regulatory changes, and engage in continuous improvement initiatives.

Benefits
  • Competitive compensation
  • Benefits that reflect local market practices and legal requirements
Things to weigh
  • Fully remote position, which may require self-discipline and effective home office setup
  • Standard work hours are Monday through Friday, 9 AM to 5 PM EST, which may not suit all candidates
  • No specific mention of additional benefits or perks beyond compensation and standard benefits
Job score2.6/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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