Quality Engineer
Posted on 3/30/2023

1,001-5,000 employees

Data-driven precision medicine
Company Overview
Tempus is on a mission to provide the necessary tools to usher in an era of precision medicine. The company has built the world's largest library of clinical and molecular data and an operating system to make that information accessible and useful for patients, physicians, and researchers.
Chicago, IL, USA
Experience Level
Desired Skills
  • 2+ years of experience in the Medical Device/Pharmaceutical regulated industry, preferably in a quality assurance or quality control role
  • Bachelor's Degree in science field is preferred
  • Demonstrate working knowledge laboratory validation experience
  • Experience with statistical analysis and application of statistical methods
  • Excellent oral and written communication, organizational, and skills are required
  • Proficient in MicroSoft Office (Word, PowerPoint, Excel, etc.)
  • Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner
  • Ability to manage multiple tasks with limited supervision
  • Prioritize numerous activities in a rapid paced environment
  • Contribute to team-oriented tasks
  • Analytical skills and ability to understand technical data
  • Decision-making skills
  • Provide quality assurance support for the laboratory quality control activities as needed
  • Performs Quality review for correctness and completeness of quality system records; Ensures all required documentation is included in records and that the documentation is accurate
  • Responsible for Acceptance Activities including; Dispositions, Incoming Material Specification documentation, SCARs, Final Release, Quarantining, Inventory Control, Reagent/Material review and approval, in-process QC activities
  • Responsible for performing Product Quarantine/MRB activities, including initiation and release
  • Support the Change Management process, including reviewing and approving change controls for process and/or product. Ensure Change implementation and follow-up for effectiveness of change
  • Participate in Non-conformance event reporting for non-conforming products, including device and/or incoming materials and reagents
  • Participate as needed in laboratory issue management activities requiring quality assurance approval and investigative support
  • Participates in Internal and External Quality System Audits as required
  • Participate in Quality Event investigations and root cause analysis as required