Senior QA Specialist — CAPA, Deviations & Regulatory Compliance

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

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.