Freenome is a private biotech company focused on developing blood tests to detect cancer early and make screening accessible for everyone. Backed by a16z, GV and CRV.
About the role
Freenome is approaching FDA approval and commercial launch of SimpleScreen™, our cfDNA-based colorectal cancer detection test. As we cross that milestone, we need a dedicated owner for the postmarket quality infrastructure that commercial launch demands — someone who can build and run a complaint handling program that works across two distinct regulatory environments. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor’s degree in life sciences, clinical laboratory science, or a closely related field
- 7+ years of quality assurance experience with direct ownership of a complaint handling or postmarket surveillance program in a regulated environment — IVD, medical device, clinical laboratory, or a combination
- Working knowledge of CAP/CLIA laboratory complaint and quality event requirements and how they differ from FDA postmarket complaint obligations under 21 CFR 820/QMSR
- Hands-on CAPA program experience: root cause analysis, corrective action implementation, effectiveness verification, and program-level trending
- Demonstrated ability to mentor or develop junior quality staff — someone who builds capability in others rather than absorbing work themselves
- Experience interfacing with external customers or commercial partners on complaint intake, communication, and resolution
More about this role
Freenome is approaching FDA approval and commercial launch of SimpleScreen™, our cfDNA-based colorectal cancer detection test. As we cross that milestone, we need a dedicated owner for the postmarket quality infrastructure that commercial launch demands — someone who can build and run a complaint handling program that works across two distinct regulatory environments.
This role also owns the CAPA program — ensuring that complaints and quality events drive real corrective action, not just documentation. You will serve as the escalation point and technical mentor for junior team members managing non-conformances and laboratory incidents, and you will be the Quality interface with our commercial partners to ensure customer and partner feedback is captured, evaluated, and acted on. This is a senior individual contributor role with significant cross-functional influence and a mentorship mandate. The role reports directly to the Senior Director, Quality Assurance and is an onsite role based in our Brisbane, California headquarters.
- Own the end-to-end complaint handling process — from intake and triage through technical investigation, root cause analysis, disposition, and closure —...
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