Remote Senior Software Quality Engineer - AI/MedTech

Tempus AI; Redwood City (CA); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Benefits package

Incentive compensation

Restricted stock units

Medical benefits

Job summary

Tempus is seeking a Senior Software Quality Engineer to strengthen the SDLC for medical device software and ensure compliance with DHF, traceability, and risk management requirements. This role supports Cybersecurity, CAPAs, audits, and change control under FDA QMSR and ISO 13485 standards.

The position partners with Product, Engineering, and Regulatory Affairs to advance digital health and AI/ML technologies within Tempus’ quality management framework.

Qualifications

• BA/BS or higher in a relevant engineering discipline.
• 5+ years in a software quality role within FDA-regulated medical device/IVD industry.
• Experience with FDA QMSR, ISO 13485, IEC 62304, ISO 14971.

Responsibilities

• Support SDLC activities for medical device software; ensure DHF deliverables are generated and maintained.
• Own compliance to QMS procedures: change control, CAPAs, NCRs, audits, management reviews, training.
• Apply risk-based approaches to optimize the QMS and integrate eQMS systems while meeting regulatory requirements.
• Stay current with regulatory landscape for Digital Health, AI/ML, and best practices in SDLC/QMS.
• Collaborate with Product, Engineering, and Regulatory Affairs; perform other QA duties as assigned.

Skills

Quality engineering

Regulatory knowledge

FDA QMSR

Education

BA/BS in Biomedical

BA/BS in Computer Science

Software Engineering degree

Tools

eQMS systems

Job description

Tempus is seeking a Senior Software Quality Engineer to strengthen the SDLC for medical device software and ensure compliance with DHF, traceability, and risk management requirements. This role supports Cybersecurity, CAPAs, audits, and change control under FDA QMSR and ISO 13485 standards.

The position partners with Product, Engineering, and Regulatory Affairs to advance digital health and AI/ML technologies within Tempus’ quality management framework.