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GeneDx

Principal Quality Engineer

GeneDx · Remote

Posted 14 days ago

or apply directly on GeneDx's site. We never take the application ourselves.

Is this posting real?

This role has been open
14 days
GeneDx's roles stay open a median of 30 days
Reposted
No
Salary listed
No
0% of GeneDx's roles list one
Ghost-job risk at GeneDx
moderate
9 stale, 0 reposted of 33 open
Hiring momentum
59 roles opened in the last 90 days
↑ up vs. the prior 90 days
Last confirmed on the employer's board
2026-09-17

Measured from postings appearing on and disappearing from GeneDx's own greenhouse board since 2026-08-03. Full hiring picture for GeneDx.

About this role

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.

Our read on this posting2.8out of 5
benefits
1/5
freshness
4/5
career value
4/5
role clarity
5/5
pay transparency
0/5

Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of GeneDx as an employer.

What you need

  • 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

Worth weighing

  • 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

Summarised from GeneDx's posting. Read the full original.

Listed by GeneDx on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.

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