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← GeneDx

Principal Quality Engineer

GeneDx
Location
Remote
Posted
18 days ago
Department
Enterprise Risk
What they actually want (must-haves)
  • Bachelor’s degree in a scientific, engineering, technical, or related discipline
  • 10+ years of progressive quality assurance or quality systems experience within a regulated environment
  • At least 6 years specifically in the IVD or medical device industry
  • Direct experience implementing or maintaining a quality management system supporting IVDs, molecular diagnostics, and/or software-enabled medical devices
  • Strong working knowledge of applicable FDA quality-system requirements and relevant standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366
  • Experience with FDA-regulated product development, design controls, risk management, software lifecycle controls, and post-market quality processes
Nice to have
  • Advanced degree preferred
  • Experience with the Ketryx platform or similar connected lifecycle management / automated compliance tools
  • ASQ CQA and/or ISO 13485 Lead Auditor certification strongly preferred
What the job really is

The Principal Quality Engineer will oversee the implementation and continuous improvement of the IVD quality management system at GeneDx. This role involves collaborating with various departments to ensure compliance with FDA requirements and ISO standards, providing quality oversight during product development, and leading quality governance activities. The engineer will also mentor quality personnel and manage supplier quality strategies while fostering a culture of quality and accountability across teams.

Things to weigh
  • Remote position with flexible work hours, but requires reliable high-speed internet access
  • Ability to travel up to 20% for supplier audits and qualification activities
  • No specific benefits listed beyond competitive compensation and local market practices
Job score2.8/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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