Remote Senior Software Quality Engineer - MedTech & AI

Tempus AI; Chicago (IL); Hybrid; USD 110,000 - 155,000; Full time

Benefits offered by this job

Full benefits

Remote work options

Job summary

Tempus AI is seeking a Senior Software Quality Engineer to ensure DHF delivery and compliance across the medical device software lifecycle.

You will own QMS processes, risk management, CAPAs, audits, and alignment with FDA QMSR, ISO 13485, IEC 62304, ISO 14971, while collaborating with Product, Engineering, and Regulatory Affairs.

This role reports to the Director, Software Quality Engineering and supports eQMS integration and evolving Digital Health governance.

Qualifications

• BA/B.S. or higher preferred in Biomedical, Computer Science, Software Engineering, or relevant engineering disciplines.
• 5+ years in a software quality role within the FDA regulated medical device/IVD (or EU MDR/IVDR) industry.
• Experience with FDA QMSR, ISO 13485, IEC 62304, ISO 14971

Responsibilities

• Ensure DHF deliverables are generated and maintained throughout lifecycle of medical device software/SaMD.
• Own project compliance to QMS procedures including change control, CAPAs, NCRs, audits, and training.
• Apply scalable, risk-based approaches to optimize the QMS and integrate eQMS systems.
• Maintain knowledge of evolving regulatory landscape for Digital Health, AI/ML, and best practices in Tempus’ SDLC processes and QMS.
• Work cross-functionally with Product, Engineering, and Regulatory Affairs.
• Perform other QA duties as assigned.

Skills

Software quality

Regulatory knowledge

FDA QMSR familiarity

Education

BA/BS in Biomedical, Computer Science, Software Engineering or related

Job description

Tempus AI is seeking a Senior Software Quality Engineer to ensure DHF delivery and compliance across the medical device software lifecycle.

You will own QMS processes, risk management, CAPAs, audits, and alignment with FDA QMSR, ISO 13485, IEC 62304, ISO 14971, while collaborating with Product, Engineering, and Regulatory Affairs.

This role reports to the Director, Software Quality Engineering and supports eQMS integration and evolving Digital Health governance.