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← GeneDx

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
  • Minimum of 3 years of Quality Engineering, Quality Assurance, supplier quality, or related experience
  • At least 2 years within an IVD, molecular diagnostics, medical-device, or similarly regulated environment
  • Experience with supplier qualification, monitoring, and performance management
  • Experience supporting post-market quality processes such as complaint handling and CAPA
  • Working knowledge of FDA quality-system requirements, ISO 13485, and ISO 14971
Nice to have
  • ASQ Certified Quality Auditor (CQA)
  • ASQ Certified Quality Engineer (CQE)
  • ISO 13485 Internal Auditor or Lead Auditor certification
What the job really is

The Quality Engineer at GeneDx focuses on supporting supplier quality and post-market quality processes for IVD products. Daily tasks include supplier qualification, monitoring, conducting audits, handling complaints, and managing nonconformances. The role also involves compiling quality metrics and ensuring compliance with quality management system standards.

Benefits
  • Fully remote position
  • Standard work hours are Monday through Friday, 9 AM to 5 PM EST
  • Ability to travel up to 20% of the time for supplier audits
  • Competitive compensation and benefits
Things to weigh
  • No specific salary range mentioned beyond the budgeted range
  • Role involves significant supplier interaction and auditing, which may require travel
  • Remote work environment may require self-discipline and effective communication skills
Job score2.8/5
Benefits2/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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