--- title: 'Postmarket Quality Manager at Freenome' canonical: 'https://feeny.ai/job/postmarket-quality-manager-freenome-brisbane-tf35b1srzbq0' type: 'job' last_seen: '2026-11-02' --- # Postmarket Quality Manager at Freenome - **Company:** Freenome - **Location:** Brisbane, CA - **Work type:** onsite - **Posted:** 2026-10-29 - **Last confirmed live:** 2026-11-02 - **Apply:** https://job-boards.greenhouse.io/freenome/jobs/8920670002 ## 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 the Senior 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 escalate with supporting 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. We invite you to check out our career page @ [freenome.com/job-openings/](http://freenome.com/job-openings/) for additional company information. 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. - https://www.dol.gov/agencies/whd/posters/fmla - https://www.dol.gov/agencies/ofccp/posters - https://www.dol.gov/agencies/whd/posters/employee-polygraph-protection-act California applicants please review the CCPA Notice at Collection here: - https://www.freenome.com/ccpa-privacy-notice-for-freenome-california-job-applicants/ #LI-Onsite ## About Freenome ## Company Overview - **One-liner**: Freenome is a biotechnology company developing blood-based multi-omics tests powered by machine learning to detect cancer in its earliest, most treatable stages. - **Entity Type**: Private (Late Stage) – raised over $2B in total funding; stock symbol FRNM (NASDAQ) is associated with a related SPAC entity but the operating company remains privately held [linkedin.com] - **Headquarters**: Brisbane, California, United States - **Founded**: 2014 - **Founders**: Riley Ennis (Co-Founder and Chief Product Officer) and others [freenome.com] ## Core Business - **Primary industry**: Biotechnology / Early Cancer Detection - **Target customers**: B2B (health systems, insurers, employers) and B2C (patients via healthcare providers) - **Mission**: To create tools that empower everyone to prevent, detect, and treat their disease, starting with early cancer detection. ## Products & Services - **Freenome Multi-Omics Blood Test (Colorectal Cancer)**: A next-generation blood test that uses a multi-omics platform (cell-free DNA, methylation, proteins, etc.) combined with machine learning to detect early-stage colorectal cancer and advanced adenomas. Type: Diagnostic test (IVD) – currently under clinical validation and regulatory review [freenome.com]. ## Market Standing - **Valuation / Market Cap**: Not publicly disclosed (private). Total funding of $2.07B (LinkedIn estimate) or $1.428B (CB Insights); conflicting reports reflect different counting methods [linkedin.com], [cbinsights.com] - **Key Metric (Funding)**: Most recent round – $75M corporate round (Nov 2025) led by Roche, plus $254M venture round (Feb 2024) also led by Roche [linkedin.com] - **Notable Investors**: Perceptive Advisors, RA Capital Management, Roche Venture Fund, Kaiser Permanente, Novartis, American Cancer Society’s BrightEdge Ventures, Exact Sciences [linkedin.com], [freenome.com] - **Growth Signals**: - Blood-based test included in updated American Cancer Society colorectal cancer screening guideline - Appointed industry veteran Rob Guigley as Chief Commercial Officer (2025) - Ongoing clinical programs for multiple cancer types - Employee headcount of 304 with 22 active job postings (as of mid-2025) [linkedin.com] ## Competitive Advantages - **Multi-omics + AI platform**: Combines multiple biological signals (DNA methylation, fragmentomics, proteins) with proprietary machine learning algorithms to achieve high sensitivity and specificity for early-stage cancer. - **Strong clinical program**: Rigorous multi-site studies and partnerships with leading health systems (e.g., Kaiser Permanente). - **Deep investor backing**: Long-term support from top healthcare investors and strategic partners (Roche, Exact Sciences) provides capital and commercial pathways. - **First-mover in multi-cancer blood screening**: Focus on colorectal cancer as first indication, with potential to expand to other cancers. ## Strategic Focus - **Clinical validation & regulatory approval**: Completing pivotal studies and preparing FDA submission for colorectal cancer test. - **Commercial launch preparation**: Building commercial team (hiring Strategic Account Executives, VP Revenue Cycle Management) and establishing relationships with payers and health systems. - **Platform expansion**: Extending multi-omics technology to additional cancer types (lung, pancreatic, etc.) through research programs. ## Why Work Here - **Mission-driven culture**: Employees are motivated by the opportunity to “outpace cancer” and make a tangible impact on patient lives. Values include integrity, empathy, trust, servant leadership, and striving for greatness [freenome.com]. - **Equity ownership**: Every U.S. full-time employee receives equity packages, aligning personal success with company milestones [freenome.com/careers]. - **Competitive benefits**: Comprehensive medical plans, wellness programs, generous PTO, 12 paid holidays, annual bonus opportunities, and market-based salaries [freenome.com/careers]. - **Collaborative environment**: Cross-functional teams across clinical, scientific, and business domains; emphasis on respect and inclusion [freenome.com/careers]. - **Work model**: Likely office-based in Brisbane, CA (hybrid flexibility not explicitly stated). The company has a physical lab and office presence. - **Engineering & science culture**: Opportunity to work with state-of-the-art multi-omics data, machine learning, and clinical trial design. The team includes senior ML scientists, computational biologists, and software engineers. ## Sources 1. [freenome.com](https://www.freenome.com/) – Company overview, leadership, values, products 2. [freenome.com/careers](https://www.freenome.com/careers/) – Benefits, culture, job openings 3. [linkedin.com/company/freenome](https://www.linkedin.com/company/freenome) – Employee count, revenue estimate, funding rounds, investor list, recent hires and departures 4. [cbinsights.com/company/freenome](https://www.cbinsights.com/company/freenome) – Funding total, company description, patent activity ## Other roles at Freenome - [Senior Systems Integration Engineer](https://feeny.ai/job/senior-systems-integration-engineer-freenome-brisbane-685r3d1r8b6w) — Brisbane, CA - [Senior Software Engineer, Site Reliability](https://feeny.ai/job/senior-software-engineer-site-reliability-freenome-remote-wmcdmqnnq13n) - [Clinical Laboratory Associate I (Contractor)](https://feeny.ai/job/clinical-laboratory-associate-i-contractor-freenome-brisbane-6z610mxzc4a3) — Brisbane, CA - [Clinical Laboratory Associate I (Contractor)](https://feeny.ai/job/clinical-laboratory-associate-i-contractor-freenome-brisbane-1b34jywjwynk) — Brisbane, CA - [Clinical Laboratory Scientist I](https://feeny.ai/job/clinical-laboratory-scientist-i-freenome-brisbane-32abdtdbq9nf) — Brisbane, CA - [Clinical Laboratory Scientist II](https://feeny.ai/job/clinical-laboratory-scientist-ii-freenome-brisbane-4h6ask34v1k9) — Brisbane, CA - [Senior Clinical Laboratory Scientist](https://feeny.ai/job/senior-clinical-laboratory-scientist-freenome-brisbane-rpddjs1faw0k) — Brisbane, CA - [Supervisor, Analytical Laboratory](https://feeny.ai/job/supervisor-analytical-laboratory-freenome-brisbane-89j954tn8spd) — Brisbane, CA - [Automation Service Engineer II](https://feeny.ai/job/automation-service-engineer-ii-freenome-brisbane-gsqf06gpzyk0) — Brisbane, CA - [Automation Service Engineer I](https://feeny.ai/job/automation-service-engineer-i-freenome-brisbane-sh4fttty91y6) — Brisbane, CA