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The Principal Quality Engineer, IVD Quality is responsible for the implementation, maintenance, and continuous improvement of the IVD quality management system, reporting to the Director, IVD Regulatory and Quality. The role ensures that QMS processes are practical, scalable, risk-based, and effectively embedded into GeneDx operations.
The role provides quality oversight and escalation support for IVD product development, partnering with Regulatory Affairs, Development Lab/R&D, Software Development, Product, Clinical/Medical Affairs, and Cybersecurity as needed. The Principal Quality Engineer advises on significant quality, compliance, product-safety, and risk-based issues to help ensure products and supporting evidence remain aligned with applicable FDA requirements, ISO standards, and GeneDx quality-system requirements.
The Principal Quality Engineer, IVD Quality is responsible for the implementation, maintenance, and continuous improvement of the IVD quality management system, reporting to the Director, IVD Regulatory and Quality. The role ensures that QMS processes are practical, scalable, risk-based, and effectively embedded into GeneDx operations.
The role provides quality oversight and escalation support for IVD product development, partnering with Regulatory Affairs, Development Lab/R&D, Software Development, Product, Clinical/Medical Affairs, and Cybersecurity as needed. The Principal Quality Engineer advises on significant quality, compliance, product-safety, and risk-based issues to help ensure products and supporting evidence remain aligned with applicable FDA requirements, ISO standards, and GeneDx quality-system requirements.
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Gaithersburg, USA
Gaithersburg, USA
Gaithersburg, USA
Gaithersburg, USA
, USA
, USA
, USA
, USA
, USA
ASQ CQA and/or ISO 13485 Lead Auditor certification strongly preferred.
This is a fully remote position. The employee will work from a home office or other suitable remote location with reliable high-speed internet access. Work is performed in a climate-controlled environment using standard office equipment including computer, phone, and video conferencing tools. Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs.
Standard work hours are Monday through Friday, 9 AM to 5 PM EST.
Ability to travel up to 20% of the time, including occasional domestic and international travel, to conduct supplier audits and support supplier qualification activities.
#LI-REMOTE
At GeneDx, we're driven by urgency and purpose: helping patients get diagnosed earlier. Our mission, to empower everyone to live their healthiest life through genomics, drives our team to make a tangible impact each day – and shapes our culture where high standards, strong teamwork, and meaningful ownership are the norm. We act with intention, support one another, and deliver work we're proud to put our names on. Here’s what you can expect day to day: 1. Play like a champion (step up, redefine what’s possible, own it)
We bring energy, focus, and a bias for action. We step up, take initiative, and deliver on our commitments – with quality, speed, and care.
We push past the obvious. We challenge assumptions, raise the bar, and make thoughtful, decisive calls — choosing progress over perfection.
We stay curious, ask questions, and share direct feedback with respect. We adapt quickly and keep learning through collaboration and continuous improvement. If you’re motivated by meaningful work, a fast-moving environment, and teammates who care deeply about outcomes, you’ll thrive at GeneDx.
We welcome everyone regardless of their background. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, age, and other characteristics protected by law.
All privacy policy information can be found here .
Public genomics company providing genetic testing and diagnostics for rare and inherited diseases to clinicians and families.
Visit company websiteJobs and hiring trendsUSD 150458-168715 yearly / year
Full-time
Senior · 10+ years experience
Remote
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