Quality Assurance Engineer

5 days ago

Salt Lake, Utah, United States Surf Search Full time $90,000 - $120,000 per year

We are searching for a Quality Assurance Engineer in Salt take city to join a growing life sciences team driving quality, compliance, and product excellence. We're looking for a hands-on QA professional to own the Quality Management System (QMS), ensure regulatory compliance, and support continuous improvement across manufacturing and product development.

Our client, a life sciences platform is accelerating innovation across drug development, diagnostics, and therapeutic solutions by offering end-to-end services—from early-stage discovery through manufacturing, commercialization, and delivery. The organization's network includes several specialized subsidiaries providing custom chemicals, reagents, assays, lipid nanoparticle design, immunoassay development, diagnostic tools, and STEM education solutions.

Requirements of the Quality Assurance Engineer:

  • Bachelor's degree in life sciences, chemistry, engineering, or related field.
  • 3+ years QA experience in biotech, biopharma, or diagnostics.
  • Strong knowledge of ISO 9001, ISO 13485, cGMP, and quality tools (CAPA, root cause analysis, process controls).
  • Detail-oriented, analytical, collaborative, and excellent communicator.
  • Experience with reagent/kit manufacturing a plus.
  • Eligible to work in the U.S., proficient in MS Office, and able to travel as needed.

Responsibilities of the Quality Assurance Engineer:

  • Lead and maintain the QMS in line with ISO 9001 and other standards.
  • Conduct audits and ensure compliance with cGMP, FDA, EU MDR, and customer requirements.
  • Monitor manufacturing processes and lead CAPA for non-conformances.
  • Manage customer complaints and provide timely, effective resolutions.
  • Analyze quality data to drive process improvements and support risk assessments and validations.
  • Train staff on quality standards and maintain training records.

Occupational Category: Engineers, All Other

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