Senior Quality Assurance Specialist

Tempus AI; Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Tempus AI in Illinois is seeking a Senior Quality Assurance Specialist to drive issue management, CAPAs, deviations and complaints in compliance with FDA 21 CFR 820, ISO 13485 and IVDR.

The role focuses on post‑market surveillance, regulatory coordination and supporting audits and inspections across the organization, on an on‑site basis. A strong background in biomedical QA and attention to detail are essential.

Qualifications

• 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/IVD regulations and standards (FDA 21 CFR 820, ISO 13485 and IVDR).
• Ability to work through complex issues in a diplomatic manner.
• Multitasks, prioritizes and meets deadlines in a timely manner.
• Strong organizational and follow-up skills, attention to detail.
• Solid communication and interpersonal skills across levels.
• Experience with PMS and/or IVD/MD Vigilance reporting a plus.
• This will be an on-site position.

Responsibilities

• Responsible for processing and managing quality issues in compliance with FDA 21 CFR 820, ISO 13485, IVDR and other applicable regulations and standards.
• Lead incident management from a quality engineering perspective.
• Participate in process improvements to the issue management reporting framework.
• Assist in Quality Data trending and monitoring efforts.
• Collaborate with Regulatory on health authority reporting.
• Support complaint analyses, failure investigations, adverse event reporting, product concerns, and field action execution.
• Provide support in audits and inspections as needed.

Skills

QA experience

Regulatory knowledge

Communication skills

Detail orientation

Education

Bachelor's degree in Engineering or Science

Job description

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.

Responsibilities include the following. Other duties may be assigned.

• 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.

Qualifications

• 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.

• Experience within the area of PMS and/or IVD/MD Vigilance reporting is a plus.

• Previous experience with external/regulatory agency audits/inspections.

• This will be an on-site position.

Illinois Pay Range: $90,000-$120,000

The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

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.