Tempus AI · 2 weeks ago
Senior Quality Engineer II
Chicago, IL
Full-time
Onsite
Mid, Senior Level
$110K/yr - $155K/yr
5+ years expTempus AI is focused on advancing the healthcare industry through precision medicine and AI technology. The Senior Quality Engineer II will be responsible for implementing quality assurance principles for the development and lifecycle management of IVD medical devices and LDT products, ensuring compliance with regulatory standards and continuous improvement of quality management systems.
Artificial Intelligence (AI)BiotechnologyHealth CareMachine LearningMedicalPrecision Medicine
Responsibilities
Responsible for implementation of quality assurance principles and practices for design, development, manufacturing, and lifecycle management of Tempus’ assay products, including medical devices and lab developed tests (LDTs)
Responsible for core team oversight of Class 3 US FDA and Class C EU IVDR compliance, including pre-market development and post-market surveillance activities, across multiple devices
Responsible for coordinating cross-functional efforts for the creation and maintenance of DHF and IVDR Technical Documentation across devices
Ensure the relevance, adequacy, and effectiveness of Tempus’ QMS and its continuous improvement with a proactive and preventive risk-based approach
Implement risk management principles per ISO 14971
Maintain and execute change management process, ensuring change impact and action items are appropriately evaluated, tested and documented
Apply medical device quality system knowledge as part of quality leadership, including but not limited to audits, nonconformances, CAPAs, supplier qualification, etc
Participate in internal and external quality system audits as required
Participate in root cause investigations as quality events/incidents arise
Share knowledge and expertise with teammates
Support other duties as assigned
Qualification
Required
5+ years of experience in the Medical Device/Pharmaceutical regulated industry
BS degree in Engineering field such as Biomedical, Bioengineering or Chemical Engineering
Experience with applicable FDA, European and other relevant clinical/regulatory requirements, international standards, including ISO 13485, ISO 14971, EU IVDR/MDR and 21 CFR 820
Experience in managing FDA or EU pre-market development and post-market surveillance activities
Experience working in a fast-paced project core-team environment
Excellent oral and written communication skills and can communicate at multiple levels in the organization
Proficient in Microsoft Office (Word, PowerPoint, Excel, etc.)
Proficient in eQMS systems (Jama, ComplianceQuest, Pilgrim SmartSolve, etc.)
This position is onsite
Benefits
Incentive compensation
Restricted stock units
Medical and other benefits depending on the position
Company
Tempus AI
Tempus is making precision medicine a reality by applying AI in healthcare, deriving insights from our expansive library of clinical data and molecular data.
1001-5000 employees
H1B Sponsorship
Tempus AI has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$2.29BKey Investors
Ares ManagementGoogleBaillie Gifford
2025-06-30Post Ipo Debt· $650M
2025-02-19Post Ipo Debt· $300M
2024-06-14IPO
Leadership Team
Eric Lefkofsky
Founder and CEO
Shane Colley
CTO
Recent News
2026-01-13
Business Wire
2026-01-13
2026-01-12
Company data provided by crunchbase