Tempus
Senior Quality Engineer
$90K–$150K
Chicago +1 · Senior · Full-time · Posted Oct 20, 2026
- Location
- Chicago
Aliso Viejo - Experience
- 5+ years in an FDA-regulated domain; 3+ years in CSV.
- Education
- BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
About the job
Leads quality and computer system validation activities for Tempus medical-device host systems, applications, and software to support regulatory compliance.
What you'll do
- Lead risk-based verification, validation, and change-control activities for host systems and software, including AI and SaaS tools.
- Develop and review validation policies, procedures, plans, requirements, protocols, and reports; collaborate on testing strategies and execution.
- Support inspections, audits, incident and change management, and provide CSV coaching to team members.
What they ask for
- 5+ years experience in an FDA-regulated domain (e.g. medical device, pharma, biotech).
- 3+ years experience in Computer System Validation (CSV).
- Experience with medical-device software and CSV standards and practices, including Design Controls, GAMP 5, FDA 21 CFR Part 11, ISO 13485:2016, and IEC 62304:2006.
- Knowledge of quality system principles, practices, and standards for the life science industry.
Nice to have
- BA/B.S. or higher in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
Pay
$90,000-$130,00 (base salary); $100,000-$150,000 (base salary)
Tools
GAMP5, Computer System Validation (CSV), AI, SaaS, FDA 21 CFR Part 11, ISO 13485:2016, IEC 62304:2006
AI focus
Validates AI applications and software as part of risk-based computer system validation.
Model-written summary · the original posting is authoritative