Postmarket Quality Manager
About The Position
Freenome is approaching FDA approval and commercial launch of SimpleScreen™, its cfDNA-based colorectal cancer detection test. The Postmarket Quality Manager will own the postmarket quality infrastructure required for commercial launch, including complaint handling across CAP/CLIA laboratory quality events and IVD postmarket complaints under 21 CFR 820/QMSR and ISO 13485. The role also owns the CAPA program and ensures complaints and quality events lead to effective corrective action. This is a senior individual contributor position with significant cross-functional influence and a mandate to mentor junior team members. The manager serves as an escalation point for non-conformances and laboratory incidents and as the Quality interface with commercial partners to ensure feedback is captured, evaluated, and acted upon. The position reports directly to the Senior Director, Quality Assurance and is onsite at Freenome’s headquarters in Brisbane, California.
Requirements
- Bachelor’s degree in life sciences, clinical laboratory science, or a closely related field.
- At least 7 years of quality assurance experience with direct ownership of a complaint handling or postmarket surveillance program in a regulated environment, such as 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, including root cause analysis, corrective action implementation, effectiveness verification, and program-level trending.
- Demonstrated ability to mentor or develop junior quality staff.
- Experience interfacing with external customers or commercial partners on complaint intake, communication, and resolution.
- Strong technical writing skills and ability to produce investigation reports, CAPA records, and trend analyses suitable for regulatory review.
- Proficiency with an electronic QMS (eQMS) platform for complaint records, CAPA tracking, and document control.
Nice To Haves
- Hands-on experience with CAP LAP inspections, including COM, GEN, and MOL checklists, and NYSDOH Part 58 laboratory permit requirements.
- Experience in a molecular diagnostics, cfDNA, or NGS-based testing environment.
- Familiarity with MDR evaluation under 21 CFR Part 803 in an LDT/IVD organization.
- Prior experience building or formalizing complaint intake processes between a clinical laboratory and commercial partners or health system clients.
- ASQ CQA or equivalent quality certification.
Responsibilities
- Own complaint handling from intake and triage through technical investigation, root cause analysis, disposition, and closure, applying relevant CAP/CLIA and IVD postmarket regulatory requirements.
- Own the CAPA program, ensuring complaints, non-conformances, and laboratory quality events result in documented root cause analysis, corrective action implementation, and effectiveness verification.
- Maintain CAPA records in the eQMS with traceability required for CAP/CLIA compliance.
- Act as the escalation point and technical mentor for junior team members managing non-conformances and laboratory incidents; coach investigation rigor, review findings, and ensure events are appropriately considered for CAPA.
- Serve as the primary Quality liaison to commercial partners and customer-facing teams for complaints and CAPA; establish processes to capture, route, and evaluate partner- and customer-reported feedback and communicate investigation status and corrective actions.
- Monitor and analyze complaint, CAPA, and non-conformance trends; identify systemic issues and escalate them to Quality leadership with supporting analysis and recommended corrective actions.
- Compile and present quality signal data, including complaint volumes, CAPA quantities and status, investigation outcomes, and trend analyses for management review and postmarket surveillance reporting.
- Participate in change control reviews and risk evaluations as the postmarket quality representative, providing historical complaint and CAPA data to inform product and process change risk assessments.
- Escalate issues to Quality leadership and serve as the Quality delegate in CAP, CLIA, NYSDOH, and FDA audit or inspection settings as appropriate.
Benefits
- Eligible to receive equity.
- Eligible to receive cash bonuses.
- Medical, financial, and other benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
