Hybrid Senior Quality Engineer, CSV & Medical Device

Tempus AI; Aliso Viejo (CA); Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Benefits package

Stock options

Medical benefits

Job summary

Tempus AI in the United States (California) is seeking a Senior Quality Engineer to lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s). The role emphasizes regulatory compliance and CSV activities.

You will collaborate across teams, develop CSV policies, lead HSV/CSV, execute validation deliverables, and mentor test engineers. The California-based hybrid role offers competitive pay and benefits.

Qualifications

• 5+ years experience in FDA regulated domain.
• 3+ years experience in Computer System Validation (CSV).
• Experience with industry standards and best practices for Medical device software and CSV such as Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA 21 CFR 820.30, Medical device software (QMS) ISO 13485:2016, FDA 21 CFR 820, and Software life cycle processes (IEC 62304:2006).
• Knowledge of quality system principles, practices, and standards for the life science industry.
• Ability to deliver quality outputs without directions or under minimal supervision.

Responsibilities

• Lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s).
• Lead risk assessments to determine testing strategies.
• Lead computer system validation (CSV) activities of Tempus AI applications, software tools, and computer systems against user, functional and regulatory requirements.
• Collaborate with cross-functional teams in developing test-driven system/functional requirements, defining testing strategies and participating in test execution.
• Support Change Management and Major Incidents (MI) processes, ensuring organizational compliance and continuous improvement.
• Provide CSV guidance, coaching, mentorship, and training to test engineers within the team.

Skills

Quality engineering

Regulatory compliance

Validation

Risk assessment

CSV

FDA standards

QMS

Software testing

Education

Bachelor's degree in Computer Science or related

Job description

Tempus AI in the United States (California) is seeking a Senior Quality Engineer to lead verification, validation and maintenance of host systems supporting Tempus Medical Device(s). The role emphasizes regulatory compliance and CSV activities.

You will collaborate across teams, develop CSV policies, lead HSV/CSV, execute validation deliverables, and mentor test engineers. The California-based hybrid role offers competitive pay and benefits.