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.
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.
We are looking for a Senior Software Quality Engineer who will
- Be involved in managing the implementation and maintenance of systems and tools that support Tempus Quality Management System (QMS), software development life cycle (SDLC) and design controls activities
- Perform and support computer system validation (CSV) activities; testing and evaluation of software tools and computer systems against user requirements
- Support medical device software design controls activities
in accordance with FDA Quality System Regulation (QSR), ISO 13485, Computer System Validation (CSV) and other applicable regulatory requirements, as well as best practices in the software industry. This position will report to the Senior Manager, Software Quality.
Responsibilities
- Implementation and maintenance of QMS software and SDLC tools:
- Manages and supports the implementation and maintenance of computer systems and software tools (such as eTQ and JAMA) that are used for the purposes of supporting the QMS, SDLC and design controls activities.
- Evaluates user needs, and suggests solutions and system configurations that support organizational compliance and quality processes.
- Defines and manages user needs and supports the execution of implementation.
- Serves as a liaison between third-party system/tool vendors during/after system implementation, and during the process of troubleshooting/resolving user experience issues.
- Facilitates system training, UAT testing activities, and scoping development of proposed system enhancements.
- Provide quality support to comply with the Computer Systems Validation (CSV) processes:
- Performs and supports the validation of regulated software applications by ensuring CSV activities, testing and evaluation of software tools and computer systems against design specifications and user requirements, are compliant to 21 CFR Part 11 and organization's CSV process.
- Works autonomously with related SMEs for this purpose.
- Supports software engineering teams as quality representative for the development, testing and implementation of computer systems and software tools.
- Collaborates with the software development team to build compliance capabilities and requirements in order to assure the quality of the deliverables and ensures business and regulatory needs are being met.
- Drives and defends validation compliance to internal/external auditors, regulatory authorities and other certified bodies.
- Ensures continuous improvement and implements inputs related to the validation strategy for systems and software tools changes.
- Ensures quality risk management principles and practices by driving teams towards risk-based approach to CSV.
- Ensures good documentation practices and assists with required documentation for compliance purposes.
- Write SOPs and various CSV deliverables, as needed.
- Provide training to project teams related to Tempus CSV standards and processes.
- Support medical device software design controls activities as assigned:
- Support writing, review and approval of DHF (Design History File) deliverables
- Support FMEA and risk management activities as per ISO 14971
Required Qualifications
- BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
- 5+ years in a quality role in the medical device/IVD (or FDA regulated) industry.
- Experience and working knowledge of applicable regulations and standards: FDA QSR, ISO 13485, IEC 62304, ISO 14971, CSV, 21 CFR Part 11.
- Experience with SDLC tools: JAMA JIRA, Atlassian, eTQ.
- Demonstrated ability to operate and innovate in teams with a fast‐paced environment, balancing business, compliance, and strategic needs.
- Experience with Agile/Scrum/iterative software development methodology.
- Excellent organizational, interpersonal, verbal and written communication skills.
- Ability to deliver quality outputs under minimal supervision.
- Flexibility to adapt to changing assignments and ability to effectively prioritize efforts.
- The role must maintain compliance expertise and be effective at applying requirements into the computer systems environment that supports business goals and maintaining a compliant state.
Chicago/National: $110,000-$155,000
NY/SF: $120,000-$165,000
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.
Additionally, for remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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.
Skills Required
- BA/B.S. or higher in Computer Science, Software Engineering, Informatics, Biomedical, or a relevant engineering discipline
- 5+ years of experience in a quality role in the medical device, IVD, or FDA-regulated industry
- Working knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971, Computer System Validation, and 21 CFR Part 11
- Experience with SDLC tools including JAMA, JIRA, Atlassian, and eTQ
- Experience with Agile, Scrum, or iterative software development methodologies
- Excellent organizational, interpersonal, verbal, and written communication skills
- Ability to deliver quality outputs under minimal supervision
- Ability to adapt to changing assignments and effectively prioritize efforts
- Ability to apply compliance requirements within computer systems environments while supporting business goals
What the Team is Saying
Tempus AI Compensation & Benefits Highlights
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Healthcare Strength — Healthcare coverage is often highlighted as broad and generally solid, with medical, dental, vision, mental-health resources, and wellness programs available. Feedback suggests these offerings add meaningful baseline value across roles.
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Leave & Time Off Breadth — Paid holidays, sick days, bereavement leave, volunteer time, and PTO are part of the package. Feedback suggests flexible or unlimited PTO is available for some roles, reinforcing perceived time-off breadth.
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Parental & Family Support — Parental leave and family-support resources, including accommodations for nursing parents, are noted positively. Feedback suggests these benefits help family-focused and early-career employees view the package more favorably.
Tempus AI Insights
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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Tempus AI Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Most of the team follows a hybrid policy, with some roles allowing for a fully remote arrangement and some roles being onsite only.
