QA Specialist – Onsite Chicago | CAPA & ISO 13485 Focus

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

Job summary

Tempus AI in Chicago, IL is seeking a QA Specialist to support quality activities for incidents, deviations, NCs, and CAPAs per FDA QSR and ISO 13485. This onsite role requires Tuesday-Saturday or Sunday-Thursday work schedules and a clinical laboratory/diagnostic background.

Responsibilities include managing NC/CAPA investigations, regulatory reporting support, and driving continual improvements to quality systems. Strong communication and leadership are essential.

Qualifications

• Bachelor’s Degree in Engineering or Science.
• 1 to 3+ years of QA experience in a clinical laboratory/medical device/Diagnostic company.
• Working knowledge of 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.
• Strong communication, influencing, negotiating and collaboration skills.
• This will be an on-site position.

Responsibilities

• Process and manage issues including deviations, NCs, and CAPAs under FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards.
• Support process improvements to the issue/incident reporting framework, ensuring systems are streamlined and aligned.
• Collaborate with Regulatory on health authority reporting as necessary.
• Assist in NC/CAPA activities, including investigations, root cause analysis, and closure.
• Drive ownership of issues/incidents to achieve final resolution and provide training to owners.
• Support departmental goals for deviations, NC and CAPA processes with minimal supervision.
• Identify trends and provide metrics to drive root cause analysis and corrective actions.
• Participate as NC/CAPA SME during internal and external audits.
• Lead or support other duties as assigned.

Skills

QA experience

Regulatory knowledge

Communication skills

Leadership

Education

Bachelor's Degree in Engineering or Science

Job description

Tempus AI in Chicago, IL is seeking a QA Specialist to support quality activities for incidents, deviations, NCs, and CAPAs per FDA QSR and ISO 13485. This onsite role requires Tuesday-Saturday or Sunday-Thursday work schedules and a clinical laboratory/diagnostic background.

Responsibilities include managing NC/CAPA investigations, regulatory reporting support, and driving continual improvements to quality systems. Strong communication and leadership are essential.