Freenome
Postmarket Quality Manager
$134K–$170K
Brisbane, California +1 · Manager · Full-time · Posted Oct 29, 2026
- Location
- Brisbane, California
Brisbane, California, United States - Experience
- 7+ years of quality assurance experience; direct ownership of a complaint handling or postmarket surveillance program required.
- Education
- Bachelor’s degree in life sciences, clinical laboratory science, or a closely related field.
About the job
Owns Freenome’s postmarket complaint handling and CAPA programs for its colorectal cancer detection test across clinical laboratory and IVD regulatory environments.
What you'll do
- Manage complaints end to end, including triage, investigation, root cause analysis, disposition, and closure.
- Lead CAPA activities and trend analysis, ensuring corrective actions are implemented and their effectiveness verified.
- Mentor junior staff and liaise with commercial partners, customers, and Quality leadership on complaints and quality events.
What they ask for
- Bachelor’s degree in life sciences, clinical laboratory science, or a closely related field.
- 7+ years of quality assurance experience, including direct ownership of a complaint handling or postmarket surveillance program in a regulated environment.
- Working knowledge of CAP/CLIA laboratory quality event requirements and FDA postmarket complaint obligations under 21 CFR 820/QMSR.
- Hands-on CAPA experience; ability to mentor junior quality staff, work with external customers or commercial partners, and use an eQMS platform.
Nice to have
- Experience with CAP LAP inspections and NYSDOH Part 58 laboratory permit requirements.
- Experience in molecular diagnostics, cfDNA, or NGS testing; familiarity with MDR evaluation under 21 CFR Part 803; ASQ CQA or equivalent certification.
Pay
$134,425 - $170,100 USD base salary
Tools
21 CFR 820/QMSR, ISO 13485, eQMS, CAP/CLIA, NYSDOH Part 58, 21 CFR Part 803, cfDNA, NGS
Model-written summary · the original posting is authoritative