Backed by NEA.
About the role
Please note: This position is onsite in Chicago and requires you to work Tuesday-Saturday or Sunday-Thursday. Participate if needed as a NC and CAPA subject matter expert during internal and external audits.
What they're looking for
- Bachelor’s Degree in Engineering or Science field
- 1 to 3+ years of QA experience in a clinical laboratory/medical device/Diagnostic company
- Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, and other applicable quality and regulatory standards)
- QA experience in a clinical molecular testing laboratory (LDTs) is required
- Working knowledge of the deviations, NC and CAPA processes
- Strong communication (written and verbal), influencing, negotiating and collaboration skills
More about this role
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.
Please note: This position is onsite in Chicago and requires you to work Tuesday-Saturday or Sunday-Thursday.
The Quality Assurance Specialist plays an integral role in supporting quality activities related to incidents and issues, including deviations, nonconformances (NC) and corrective and preventive actions (CAPA) in accordance with FDA QSR (Quality System Regulation), ISO 13485, and other applicable global regulations. This individual also supports the QMS activities that comply with CLIA/CAP requirements for the clinical laboratories.
Responsibilities include the following. Other duties may be assigned.
Responsible for processing and managing issues/incidents that include deviations, NCs, and CAPAs, as well as ensuring compliance to FDA 21...
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