Senior Quality Engineer

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time actionable insights to physicians providing critical information about the right treatments for the right patients at the right time.

As a Senior Quality Engineer you will:

• Lead verification validation and maintenance of host systems supporting Tempus Medical Device(s).

• Lead risk assessments to determine testing strategies.

• Be involved in the medical device software design controls activities in accordance with the FDA Quality System Regulation ISO 13485 GAMP5 Computer System Validation (CSV) standards and FDA guidance other applicable regulatory requirements as well as best practices in the software industry.  

• Lead computer system validation (CSV) activities of Tempus AI applications software tools and computer systems against user functional and regulatory requirements.

Responsibilities:

• Support regulatory compliance of the host system operating with Tempus Medical Device(s).

• Develop and maintain CSV policies procedures templates and work instructions.

• Lead risk-based approach to host / computer system validation (HSV/CSV) SDLC and design controls activities.

• Perform validation re-validation and change controls of various AI SaaS and Tempus in-house developed software.

• Author and review software validation deliverables including Risk Assessments Validation Plans Requirements (URS) Validation Protocols (IQ OQ PQ) UAT (User Acceptance Test) and Validation Reports. 

• 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 support to Quality and IT organizations in maintaining compliance to various policies procedures and activities including support during internal/external inspections and regulatory and customer audits.

• Provide CSV guidance coaching mentorship and training to test engineers within the team. 

Qualifications

•  BA/B.S. or higher preferred in Computer Science Software Engineering Informatics Biomedical or relevant engineering disciplines.

• 5+ years experience in FDA regulated domain (e.g. medical device pharma biotech) 

• 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 (QSR) 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.

CHI: $75000-$100000

The expected salary range above is applicable if the role is performed from California and may vary for other locations (Colorado Illinois New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits which may include incentive compensation restricted stock units medical and other benefits depending on the position.

We are an equal opportunity employer. We do not discriminate on the basis of race religion color national origin gender sexual orientation age marital status veteran status or disability status. 

What We Do

We bring together one of the world’s largest libraries of multimodal clinical and molecular data with a robust suite of AI tools to help physicians personalize care in real time connect patients with therapies and clinical trials and enable partners to accelerate discovery and development of new treatments. With ~8 million de-identified research records and 350+ petabytes of data Tempus partners with more than half of U.S. oncologists and the majority of the top 20 global pharma companies. Our teams are pioneering work across oncology neurology psychiatry cardiology and beyond—transforming how care is delivered and therapies are developed. At Tempus every role contributes to our mission: to help each patient benefit from the experiences of those who came before. For more information visit tempus.com.

Why Work With Us

We’re looking for people who can change the world. People who question the status quo and refuse to shy away from tough problems. For builders who are never done building and the learners who are never done learning. Passionate individuals with undying curiosity who want to take on one of the greatest challenges humanity has ever faced—head on.

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