Sr. Quality Engineer

Tempus AI, Inc.; Chicago (IL); On-site; USD 110,000 - 155,000; Full time

Job summary

Tempus AI, Inc. seeks a Senior Software Quality Engineer to support the SDLC of medical device software, ensuring DHF artifacts and design controls meet FDA QMSR, ISO 13485, and IEC 62304.

You will drive risk management, traceability, cybersecurity, CAPAs, audits, and training while collaborating with Product, Engineering, and Regulatory Affairs to maintain compliance across the life cycle.

Qualifications

• BA/BS or higher in biomedical, CS, software engineering
• 5+ years in FDA-regulated medical device software quality
• Experience with FDA QMSR, ISO 13485, IEC 62304, ISO 14971

Responsibilities

• Support SDLC activities and ensure DHF deliverables are generated and maintained
• Apply risk-based approaches to evolve the QMS and integrate eQMS systems
• Collaborate with Product, Engineering, and Regulatory Affairs on QA activities

Skills

Software Quality

Regulatory Compliance

FDA QMSR

Education

BA/BS or higher in Biomedical/CS

Job description

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 Support Tempus’ software development lifecycle (SDLC) activities for medical device software by ensuring Design and Development file (DHF) documentation and are generated, maintained, and compliant throughout the product lifecycle. This role will support requirements, architecture, verification and validation, traceability, risk management, cybersecurity, and quality-system activities including CAPAs, change control, audits, and training. The Senior Software Quality Engineer will apply scalable, risk-based approaches to evolve Tempus’ QMS for novel digital health, AI, and machine-learning technologies, while ensuring alignment with FDA QMSR, ISO 13485, IEC 62304, ISO 14971, and other applicable regulatory requirements. This position will report to the Director, Software Quality Engineering.

Responsibilities

Support Tempus’ SDLC activities for medical device software by ensuring required documentation and Design and Development file (aka DHF) deliverables are generated and maintained throughout lifecycle of medical device software/SaMD, including: SRS, SAD, SDS, V&V Traceability Risk management/FMEA Cybersecurity Own project compliance to various QMS procedures and activities including: Change control CAPAs and NCRs internal and external audits management reviews training Apply innovative, scalable and risk-based approaches to optimize the QMS, including integrating eQMS systems, while meeting compliance for novel technologies. Maintain knowledge of the evolving regulatory landscape for Digital Health, Artificial Intelligence and Machine Learning technologies, and incorporate best practices in Tempus’ SDLC processes and QMS. Work cross functionally with project teams, including Product, Engineering, and Regulatory Affairs Performs other Quality Assurance related duties and responsibilities as assigned.

Required Qualifications

BA/B.S. or higher preferred in Biomedical, Computer Science, Software Engineering, or relevant engineering disciplines. 5+ years in a software quality role within the FDA regulated medical device/IVD (or EU MDR/IVDR) industry. Experience and working knowledge of applicable regulations and standards: FDA QMSR, ISO 13485, IEC 62304, ISO 14971

Preferred Qualifications

Familiarity with various QMS approaches and consolidating multiple QMS Experience with FDA Class I and II AI/ML-enabled software, including LLM-based agents ASQ CSQE or comparable quality/regulatory certification

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.

Tempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company’s first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real time healthcare data in an effort to personalize diagnostics. We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology.

Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives.

We’re looking for people who can change the world. Who question the status quo and don’t shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We’re looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.