Remote Senior Quality Engineer – Medical AI/SDLC

Tempus AI, Inc.; Chicago (IL); On-site; USD 110,000 - 155,000; Full time

Job summary

Tempus AI, Inc. seeks a Senior Software Quality Engineer to support the SDLC of medical device software, ensuring DHF artifacts and design controls meet FDA QMSR, ISO 13485, and IEC 62304.

You will drive risk management, traceability, cybersecurity, CAPAs, audits, and training while collaborating with Product, Engineering, and Regulatory Affairs to maintain compliance across the life cycle.

Qualifications

• BA/BS or higher in biomedical, CS, software engineering
• 5+ years in FDA-regulated medical device software quality
• Experience with FDA QMSR, ISO 13485, IEC 62304, ISO 14971

Responsibilities

• Support SDLC activities and ensure DHF deliverables are generated and maintained
• Apply risk-based approaches to evolve the QMS and integrate eQMS systems
• Collaborate with Product, Engineering, and Regulatory Affairs on QA activities

Skills

Software Quality

Regulatory Compliance

FDA QMSR

Education

BA/BS or higher in Biomedical/CS

Job description

Tempus AI, Inc. seeks a Senior Software Quality Engineer to support the SDLC of medical device software, ensuring DHF artifacts and design controls meet FDA QMSR, ISO 13485, and IEC 62304.

You will drive risk management, traceability, cybersecurity, CAPAs, audits, and training while collaborating with Product, Engineering, and Regulatory Affairs to maintain compliance across the life cycle.