Tempus
Quality Assurance Specialist
$55K–$70K
Chicago · Full-time · Posted Oct 20, 2026
- Experience
- 1 to 3+ years of QA experience in a clinical laboratory/medical device/Diagnostic company.
- Education
- Bachelor’s Degree in Engineering or Science field.
About the job
Supports quality management activities by managing laboratory and medical-device quality incidents, deviations, nonconformances, and CAPAs through investigation, resolution, and closure.
What you'll do
- Process and manage deviations, nonconformances, and CAPAs, ensuring compliance with applicable quality regulations and standards.
- Support investigations, root-cause analysis, effectiveness verification, and closure; guide issue owners and identify trends and metrics.
- Improve incident-reporting processes and collaborate with Regulatory on health-authority reporting and with audit teams as needed.
What they ask for
- Bachelor’s Degree in Engineering or Science field.
- QA experience in a clinical molecular testing laboratory (LDTs) is required.
- Working knowledge of medical device / in vitro diagnostic regulations and deviation, NC, and CAPA processes.
- Strong communication, collaboration, and problem-solving skills; ability to manage multiple tasks with limited supervision.
Pay
$55,000-$70,000 USD base salary
Tools
FDA 21 CFR 820, ISO 13485, IVDD, CAP/CLIA
Model-written summary · the original posting is authoritative