Remote Senior Quality Engineer - Medical Device Software

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

Job summary

Tempus AI seeks a Senior Software Quality Engineer to help scale our medical device software quality program. You will manage QMS tooling, SDLC support, CSV activities and design controls aligned with FDA QSR, ISO 13485 and 21 CFR Part 11 to ensure compliant, high-quality deliverables.

You will collaborate with software engineers and SMEs, drive validation activities, support DHF deliverables, and contribute to risk management per ISO 14971 while promoting continuous improvement across the team.

Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical, or related field.
• 5+ years in a quality role in the medical device/IVD or FDA-regulated industry.
• Experience with FDA QSR, ISO 13485, IEC 62304, ISO 14971, CSV, 21 CFR Part 11.
• Experience with SDLC tools: JAMA JIRA, Atlassian, eTQ.
• Strong teamwork in fast-paced environments with strong communication.

Responsibilities

• Implement and maintain QMS software and SDLC tools for quality processes.
• Support CSV activities, validate regulated software against design specs and user requirements.
• Collaborate with software teams to ensure quality deliverables and regulatory compliance.
• Write SOPs and CSV documentation; provide training on Tempus CSV standards.

Skills

Communication skills

Agile/Scrum

Team collaboration

Regulatory understanding

Problem solving

Education

B.S. in Computer Science or related field

Tools

JAMA

JIRA

Atlassian

eTQ

Job description

Tempus AI seeks a Senior Software Quality Engineer to help scale our medical device software quality program. You will manage QMS tooling, SDLC support, CSV activities and design controls aligned with FDA QSR, ISO 13485 and 21 CFR Part 11 to ensure compliant, high-quality deliverables.

You will collaborate with software engineers and SMEs, drive validation activities, support DHF deliverables, and contribute to risk management per ISO 14971 while promoting continuous improvement across the team.