Hiring: Sr. Manager, Quality Assurance Company: Tempus AI Location: Chicago, IL Job Posted Time: 2026-09-03 10:20:56 Employment Type: Hybrid About the job Experience: •Solid functional working knowledge of CAP/CLIA/NYS regulations and requirements to support relevant QMS activities. •Solid functional working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD/IVDR, and other applicable quality and regulatory standards). •QA experience with Class 2 or 3 medical device development and/or in a molecular testing laboratory (LDTs) is preferable. •Strong communication (written and verbal), leadership, influencing & negotiating and collaboration skills. •Demonstrated capacity to manage multiple tasks with limited supervision. Required Skills: •Act as a change leader, responsible for execution of major readiness and compliance initiatives. Qualifications: •Bachelor’s Degree in Engineering or Science field or with 8+ years of relevant working experience in a clinical laboratory/medical device/Diagnostic company, with a minimum of 5 years working on QA activities such as audits, complaints, NC, CAPA, Document Control. •Demonstrated capacity to work through complex issues and differences in a creative, constructive, and diplomatic manner. Compensation: •$100,000 - $160,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!