Sr. Quality Engineer

Tempus AI; New York (NY); Sur place; USD 120 000 - 165 000; Plein temps

Résumé du poste

Tempus AI seeks a Senior Software Quality Engineer to ensure DHF deliverables and SDLC compliance for medical device software. You will drive risk management, traceability, cybersecurity, and quality-system activities including CAPAs, change control, audits, and training.

You will apply scalable, risk-based approaches to evolve Tempus’ QMS for digital health and AI/ML technologies, aligning with FDA QMSR, ISO 13485, IEC 62304, and ISO 14971.

Qualifications

• Bachelor-level degree in Biomedical, CS, or engineering.
• 5+ years in software quality within FDA-regulated medical devices.
• Experience with FDA QMSR, ISO 13485, IEC 62304, ISO 14971.

Responsabilités

• Support SDLC activities and ensure DHF deliverables.
• Own QC processes including change control, CAPAs, audits, training.
• Improve QMS integrating eQMS and regulatory alignment.
• Coordinate with Product, Engineering, Regulatory Affairs.
• Perform other QA duties as assigned.

Connaissances

Software Quality

FDA Regulated MD

Regulatory Standards

Cybersecurity

Formation

B.S. in Biomedical/CS/Engineering

Description du poste

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.

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.