Lead Quality Engineer

The Lead Quality Engineer will work in a multidisciplinary team of subject‑matter experts in the development and sustaining of Tempus’ In Vitro Diagnostics (IVD) medical devices and Laboratory Developed Test (LDT) products. Responsibilities Implement quality assurance principles and practices for design, development, manufacturing, and lifecycle management of Tempus’ assay products, including medical devices and lab developed tests. Oversee core team operations for Class 3 US FDA and Class C EU IVDR compliance, including pre‑market development and post‑market surveillance activities across multiple devices. Own the EU post‑market surveillance framework and deliverables, such as PMS plans, periodic safety update reports, post‑market performance follow‑up plans and reports. Identify PMS trends for Management Review. Coordinate cross‑functional efforts for the creation and maintenance of Design History File (DHF) and IVDR technical documentation across devices. Conduct investigational device development, clinical performance, and lifecycle management according to US FDA and EU IVDR requirements. Ensure relevance, adequacy, and effectiveness of Tempus’ QMS and pursue continuous improvement with a proactive, preventive risk‑based approach. Implement risk management principles per ISO 14971, including EU PMS risks. Maintain and execute change management process, ensuring change impact and action items are evaluated, tested and documented. Apply medical device quality system knowledge in audits, nonconformances, CAPAs, supplier qualification, etc. Participate in internal and external quality system audits as required. Conduct root cause investigations for quality events/incidents. Share knowledge and expertise with teammates. Support other duties as assigned. Qualifications 5+ years of experience in the Medical Device/Pharmaceutical regulated industry. BS degree in Engineering (Biomedical, Bioengineering, or Chemical Engineering). Experience with applicable FDA, European and other relevant clinical/regulatory requirements, including ISO 13485, ISO 14971, EU IVDR/MDR and 21 CFR 820. Experience 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. Proficient in Microsoft Office and eQMS systems (Jama, ComplianceQuest, Pilgrim SmartSolve, etc.). Compensation & Location Onsite positions in Illinois: $110,000–$155,000. Remote roles in California: $120,000–$165,000. Pay ranges may vary by location and qualifications. Tempus is open to individuals in unincorporated Los Angeles for remote roles. Criminal history may be considered under applicable law. Benefits Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. EEO Statement 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. 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. #J-18808-Ljbffr Tempus AI, Inc.