Tempus
Sr. Quality Engineer
$110K–$165K
Chicago +2 · Senior · Full-time · Posted Oct 27, 2026
- Location
- Chicago
Redwood City
New York City - Experience
- 5+ years in a quality role in the medical device/IVD (or FDA regulated) industry.
- Education
- BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
About the job
Manages quality systems and computer system validation for regulated software tools, while supporting software development lifecycle and medical device design controls compliance.
What you'll do
- Implement and maintain QMS and SDLC software tools; assess user needs, coordinate vendors, and facilitate training and UAT.
- Perform and support computer system validation, documentation, risk management, and audit readiness under applicable regulatory requirements.
- Support medical device software design controls, including Design History File deliverables and FMEA/risk management activities.
What they ask for
- 5+ years in a quality role in the medical device/IVD (or FDA regulated) industry.
- Working knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971, CSV, and 21 CFR Part 11.
- Experience with SDLC tools: JAMA JIRA, Atlassian, eTQ.
- Experience with Agile/Scrum/iterative software development methodology.
Nice to have
- BA/B.S. or higher in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
Pay
$110,000-$155,000 (base salary); $120,000-$165,000 (base salary)
Tools
eTQ, JAMA, JIRA, Atlassian, FDA QSR, ISO 13485, IEC 62304, ISO 14971
Model-written summary · the original posting is authoritative