Onsite Quality Assurance & CAPA Specialist — Chicago

Tempus; Chicago, Northern (IL, KY); Hybrid; USD 55,000 - 70,000; Full time

Job summary

Tempus is seeking a Quality Assurance Specialist to support quality activities for incidents and CAPA processes in a FDA QSR and ISO 13485 environment. This on-site Chicago role requires coordinating NCs, deviations, CAPAs, and CAP/CLIA compliance while working with cross-functional teams.

You will participate in audits, drive root-cause analyses, track metrics, and implement process improvements. A science/engineering degree and 1–3+ years QA experience in a clinical lab are required.

Qualifications

• Bachelor's degree in engineering or science.
• 1–3+ years of QA experience in a clinical laboratory/medical device setting.
• Working knowledge of FDA 21 CFR 820, ISO 13485 and related standards.

Responsibilities

• Process and manage issues including deviations, NCs, and CAPAs.
• Support NC/CAPA investigations with root cause analysis and verification.
• Collaborate with Regulatory on health authority reporting as needed.
• Lead training to owners to ensure timely closure of issues.
• Identify trends and drive corrective actions to prevent recurrence.
• Assist in audits as a CAPA/NC SME.

Skills

Regulatory compliance

QA experience

Communication

Leadership

Education

Bachelor's Degree in Engineering or Science

Tools

Quality systems knowledge

Job description

Tempus is seeking a Quality Assurance Specialist to support quality activities for incidents and CAPA processes in a FDA QSR and ISO 13485 environment. This on-site Chicago role requires coordinating NCs, deviations, CAPAs, and CAP/CLIA compliance while working with cross-functional teams.

You will participate in audits, drive root-cause analyses, track metrics, and implement process improvements. A science/engineering degree and 1–3+ years QA experience in a clinical lab are required.