Senior Quality Engineer

Tempus AI

. Lead verification, validation and maintenance of host systems supporting Tempus Medical Devices .

Posted 10/14/2026full-timeUnited StatesSenior💰 $90,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computer System Validation (CSV) and risk management within FDA regulated environments, with a strong focus on compliance and quality assurance in medical device software development. Proficient in leading cross-functional teams and developing validation documentation to ensure regulatory adherence.

Highest-signal resume keywords

Computer System Validation (CSV)Risk AssessmentDesign ControlsFDA RegulationsQuality System Principles

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation PlansRisk AssessmentsChange ControlsSoftware Life Cycle ProcessesTest ExecutionURDIQ/OQ/PQ ProtocolsUser Acceptance Testing (UAT)GAMP 5ISO 13485:2016

Soft Skills

CollaborationMentorshipCoachingIndependent WorkMinimal Supervision

Industry Keywords

FDA 21 CFR Part 11FDA 21 CFR 820.30FDA 21 CFR 820IEC 62304:2006Life Science IndustryMedical DevicePharmaBiotech

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Lead verification, validation and maintenance of host systems supporting Tempus Medical Devices
Lead risk assessments to determine testing strategies
Participate in medical device software design controls activities
Lead computer system validation (CSV) activities for Tempus AI applications, software tools, and computer systems
Support regulatory compliance of host systems operating with Tempus Medical Devices
Develop and maintain CSV policies, procedures, templates, and work instructions
Lead risk-based host/computer system validation, SDLC, and design controls activities
Perform validation, re-validation, and change controls for AI, SaaS, and in-house-developed software
Author and review software validation deliverables, including risk assessments, validation plans, URS, IQ/OQ/PQ protocols, UAT, and validation reports
Collaborate with cross-functional teams on test-driven system/functional requirements, testing strategies, and test execution
Support Change Management and Major Incidents processes
Support Quality and IT organizations during inspections and regulatory and customer audits
Provide CSV guidance, coaching, mentorship, and training to test engineers

Requirements

What you’ll need

BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines
5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech)
3+ years experience in Computer System Validation (CSV)
Experience with Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA 21 CFR 820.30, ISO 13485:2016, FDA 21 CFR 820, IEC 62304:2006, and software life cycle processes
Knowledge of quality system principles, practices, and standards for the life science industry
Ability to deliver quality outputs without directions or under minimal supervision

Benefits

Comp & perks

Incentive compensation may be offered
Restricted stock units may be offered
Medical and other benefits depending on the position
Equal opportunity employment