Postmarket Quality Manager

Regulatory Toolkit; California; On-site; USD 134,000 - 170,000; Full time

Benefits offered by this job

Equity

Cash bonuses

Full medical benefits

Job summary

Freenome is seeking a senior quality leader to own the postmarket complaint handling program and CAPA across regulated environments. Based in Brisbane, CA, this onsite role collaborates with teams to ensure customer feedback is captured and acted on, and serves as the quality interface with commercial partners.

You will mentor junior staff, drive root-cause analysis, and ensure CAPA records, trend analyses, and regulatory documentation meet 21 CFR 820/QMSR and ISO 13485 requirements.

Qualifications

• Bachelor’s degree in life sciences, clinical laboratory science, or a closely related field.
• 7+ years of quality assurance experience with ownership of a complaint handling or postmarket surveillance program in a regulated environment.
• Working knowledge of CAP/CLIA laboratory complaint and quality event requirements and how they differ from FDA postmarket obligations.
• Hands-on CAPA program experience: root cause analysis, corrective action implementation, effectiveness verification, and 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; ability to produce clear investigation reports, CAPA records, and trend analyses for regulatory review.
• Proficiency with an electronic QMS (eQMS) platform for complaint records, CAPA tracking, and document control.

Responsibilities

• Own the end-to-end complaint handling process—from intake to closure—under CAP/CLIA and 21 CFR 820/QMSR and ISO 13485.
• Own the CAPA program: ensure rigorous corrective action with root cause analysis and effectiveness verification.
• Mentor junior team members on investigations and non-conformances and coach quality events into CAPA.
• Serve as Quality liaison to commercial partners for feedback and complaints and communicate investigations.
• Monitor trends across quality streams; identify systemic issues and recommend corrective actions.
• Compile quality signals data for management review and postmarket surveillance reporting.
• Participate in change control reviews and risk evaluations as postmarket quality representative.
• Support audits/inspections as Quality delegate and provide historical data as needed.

Skills

CAPA program

Quality Assurance

Technical writing

eQMS proficiency

Regulatory knowledge

Mentoring

Education

Bachelor's degree in life sciences

Tools

eQMS software

Job description

About this opportunity:

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 theSenior Director, Quality Assurance and is an onsite role based in our Brisbane, California headquarters.

What you’ll do:

• Own the end-to-end complaint handling process — from intake and triage through technical investigation, root cause analysis, disposition, and closure — applying the distinct regulatory requirements applicable to CAP/CLIA laboratory quality events and IVD postmarket complaints under 21 CFR 820/QMSR and ISO 13485.
• Own the CAPA program: ensure that complaints, non-conformances, and laboratory quality events drive rigorous corrective action with documented root cause analysis, implementation, and effectiveness verification. Maintain CAPA records in the eQMS with traceability required for CAP/CLIA compliance.
• Serve as the escalation point and technical mentor for junior team members managing non-conformances and laboratory incidents — coaching investigation rigor, reviewing findings, and ensuring quality events at all levels feed appropriately into the CAPA program.
• Serve as the primary Quality liaison to commercial partners and customer-facing teams as it relates to complaints and CAPA: establish and maintain processes for capturing, routing, and evaluating partner- and customer-reported feedback and complaints, and communicate investigation status and corrective actions back to relevant stakeholders.
• Monitor and analyze complaint, CAPA, and non-conformance trends across all quality event streams; identify systemic issues and support with analysis and recommended corrective actions to Quality leadership.
• Compile and present quality signals data: complaint volumes, CAPA quantities and their status, investigation outcomes, and trend analysis for management review and postmarket surveillance reporting.
• Participate in change control reviews and risk evaluations as the postmarket quality representative; provide historical complaint and CAPA data to inform risk assessments for product and process changes.
• Escalate issues to Quality leadership and serve as the Quality delegate in CAP, CLIA, NYSDOH, and FDA audit or inspection settings as appropriate.

Must haves:

• 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.
• Strong technical writing skills; ability to produce clear 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 (COM, GEN, 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 the context of 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.

Benefits and additional information:

The US target range of our base salary for new hires is $134,425 - $170,100. You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education.

Freenome is proud to be an equal‑opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

California applicants please review the CCPA Notice at Collection here:

• California Consumer Privacy Act (CCPA)

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