Senior Quality Engineer
Core
Lead verification, validation, and maintenance of host systems and AI applications supporting Tempus Medical Devices to ensure regulatory compliance and clinical safety.
Role type
Senior Quality Engineer (Medical Device Software)
Builds
FDA-regulated medical device software and AI applications
Domain
Healthcare / Medical Device / AI
Deliverable
production ML models | infrastructure
Required skills
Computer System Validation (CSV), FDA 21 CFR Part 11, ISO 13485, GAMP 5, Design Controls, Risk Assessment, Change Management, User Acceptance Testing (UAT), Software Life Cycle Processes (IEC 62304)
Preferred skills
Biomedical or Software Engineering background, experience in life science industry quality systems
Technologies
AI applications, SaaS, host systems
Responsibilities
Lead verification, validation, and maintenance of host systems; Lead risk assessments to determine testing strategies; Lead computer system validation (CSV) activities; Author and review software validation deliverables including Validation Plans, Protocols, and Reports; Collaborate with cross-functional teams to define testing strategies; Provide CSV guidance, coaching, and mentorship to test engineers.
Seniority
Senior, hands-on IC with mentorship responsibilities