Senior Software Quality Engineer - Medical AI (Remote)

Tempus AI; New York (NY); On-site; USD 120,000 - 165,000; Full time

Job summary

Tempus AI seeks a Senior Software Quality Engineer to ensure DHF deliverables and SDLC compliance for medical device software. You will drive risk management, traceability, cybersecurity, and quality-system activities including CAPAs, change control, audits, and training.

You will apply scalable, risk-based approaches to evolve Tempus’ QMS for digital health and AI/ML technologies, aligning with FDA QMSR, ISO 13485, IEC 62304, and ISO 14971.

Qualifications

• Bachelor-level degree in Biomedical, CS, or engineering.
• 5+ years in software quality within FDA-regulated medical devices.
• Experience with FDA QMSR, ISO 13485, IEC 62304, ISO 14971.

Responsibilities

• Support SDLC activities and ensure DHF deliverables.
• Own QC processes including change control, CAPAs, audits, training.
• Improve QMS integrating eQMS and regulatory alignment.
• Coordinate with Product, Engineering, Regulatory Affairs.
• Perform other QA duties as assigned.

Skills

Software Quality

FDA Regulated MD

Regulatory Standards

Cybersecurity

Education

B.S. in Biomedical/CS/Engineering

Job description

Tempus AI seeks a Senior Software Quality Engineer to ensure DHF deliverables and SDLC compliance for medical device software. You will drive risk management, traceability, cybersecurity, and quality-system activities including CAPAs, change control, audits, and training.

You will apply scalable, risk-based approaches to evolve Tempus’ QMS for digital health and AI/ML technologies, aligning with FDA QMSR, ISO 13485, IEC 62304, and ISO 14971.