Senior Quality Assurance Specialist

Tempus AI•Chicago, IL

4d•$90,000 - $120,000•Onsite

About The Position

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. The Senior Quality Assurance Specialist plays an integral role in supporting quality activities related to issue management, including deviations, nonconformances (NC), corrective and preventive actions (CAPA) and complaints, in accordance with FDA Quality System Regulation, ISO 13485, IVDR and other applicable global regulations and standards. The Sr Quality Engineer will also be responsible for Post Market Surveillance activities. Additionally, the Sr Quality Engineer supports the QMS activities that comply with CAP/CLIA requirements for the clinical laboratories.

Requirements

Bachelor's degree in Engineering or Science field.
3+ years of QA experience in a clinical laboratory/medical device/diagnostics company, with a minimum of 3 years working on nonconformances, CAPAs and complaints.
Working knowledge and practical application of medical device/in vitro diagnostics (IVD) regulations and standards (.e.g. FDA 21 CFR 820, ISO 13485 and IVDR), specifically in the issue management processes.
Ability to work through complex issues and differences in a creative, constructive and diplomatic manner.
Multitasks, prioritizes and meets deadlines in a timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Solid communication (written and verbal) and interpersonal skills, with ability to effectively communicate at multiple levels in the organization.

Nice To Haves

Experience within the area of PMS and/or IVD/MD Vigilance reporting is a plus.
Previous experience with external/regulatory agency audits/inspections.

Responsibilities

Responsible for processing and managing quality issues (deviations, NCs, CAPAs and complaints) in compliance with FDA 21 CFR 820, ISO 13485, IVDR, CAP/CLIA and other applicable regulations and standards.
Lead incident management from a quality engineering perspective, collaborating cross functionally as needed to resolve incidents and improve process and product quality.
Participate in process improvements to the issue management reporting framework by helping identify areas for improvement, simplification, and standardization, ensuring that the various systems are streamlined and aligned.
Assist in Quality Data trending and monitoring efforts within the Quality Assurance organization.
Collaborate with Regulatory on appropriate health authority reporting, as necessary.
Support complaint analyses, failure investigations, adverse event reporting, product concerns, and field action execution.
Provide support in audits and inspections as needed.