Quality Engineer

1 week ago


Denver, Colorado, United States System One Full time
About the Job

We are hiring an experienced Quality Engineer - Medical Devices to oversee supplier quality programs, conduct audits, and ensure compliance with industry regulations.

The ideal candidate will have 6+ years of experience in Supplier Quality Engineering within the medical device industry and strong knowledge of FDA, ISO 13485, and ISO 9001 standards.

This role offers a competitive salary + 7% bonus, flexible hybrid work schedule, and comprehensive benefits including health, dental, vision, 401(k) matching, and more.

Key Skills and Qualifications
  • Bachelor's degree in Engineering or a related field (advanced degree preferred).
  • Strong knowledge of FDA, ISO 13485, and ISO 9001 standards.
  • Experience with supplier audits and root cause analysis.


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