Hiring: Senior Quality Engineer Company: Tempus AI Location: Chicago, IL Job Posted Time: 2026-09-11 10:20:56 Employment Type: Remote Target Skills & Keywords : Regulatory Compliance, SaaS About the job Experience: •5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech) •3+ years experience in Computer System Validation (CSV). Required Skills: •Support regulatory compliance of the host system operating with Tempus Medical Device(s). •Develop and maintain CSV policies, procedures, templates and work instructions. •Lead risk-based approach to host / computer system validation (HSV/CSV), SDLC and design controls activities. •Perform validation, re-validation and change controls of various AI, SaaS, and Tempus in-house developed software. •Author and review software validation deliverables, including Risk Assessments, Validation Plans, Requirements (URS), Validation Protocols (IQ, OQ, PQ), UAT (User Acceptance Test), and Validation Reports. •Partner cross-functionally with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution. •Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement. •Provide support to Quality and IT organizations in maintaining compliance to various policies, procedures and activities, including support during internal/external inspections and regulatory and customer audits. Qualifications: •BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines. •Knowledge of quality system principles, practices, and standards for the life science industry. •Demonstrated capacity to deliver quality outputs without directions or under minimal supervision. Compensation: •$90,000 - $130 / year •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!