Quality Assurance Specialist - Clinical Lab CAPA & Compliance

Tempus AI, Inc.; Chicago (IL); On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Benefits including incentive comp

Restricted stock units

Medical and other benefits

Job summary

Tempus AI, Inc. in Chicago is hiring a Quality Assurance Specialist to support FDA QSR, ISO 13485 and CLIA/CAPAs in a clinical lab/diagnostic setting. You will manage NCs, CAPAs, deviations and investigations, ensuring alignment with global quality standards.

Responsibilities include trend analysis, cross-functional collaboration with Regulatory, and driving improvements to incident reporting and corrective actions while maintaining timely training and closure of issues.

Qualifications

• Bachelor's degree in engineering or science required.
• 1 to 3+ years of QA experience in a clinical laboratory/medical device/diagnostic company.
• Working knowledge of medical device and regulatory standards (FDA 21 CFR 820, ISO 13485, IVDD).
• QA experience in a clinical molecular testing laboratory (LDTs) required.
• Familiar with deviations, NC and CAPA processes.
• Strong communication, collaboration and leadership abilities.

Responsibilities

• Support quality activities related to incidents, deviations, NCs and CAPAs per FDA/ISO requirements.
• Assist CLIA/CAP regulatory compliance for clinical laboratories.
• Manage issue tracking, investigations and root cause analysis.
• Collaborate cross-functionally to improve the incident reporting framework.
• Assist regulatory reporting and drive timely closure and training.

Skills

QA experience

Regulatory knowledge

Communication skills

Leadership

Education

Bachelor's Degree in Engineering or Science

Job description

Tempus AI, Inc. in Chicago is hiring a Quality Assurance Specialist to support FDA QSR, ISO 13485 and CLIA/CAPAs in a clinical lab/diagnostic setting. You will manage NCs, CAPAs, deviations and investigations, ensuring alignment with global quality standards.

Responsibilities include trend analysis, cross-functional collaboration with Regulatory, and driving improvements to incident reporting and corrective actions while maintaining timely training and closure of issues.