# Postmarket Quality Manager at Freenome

> Onsite · United States · Manager · Software engineering · open. Source: https://alderhq.app/jobs/greenhouse%3Afreenome%3A8920670002 (read 2026-11-10).

## Facts (observed)

- Company: [Freenome](https://alderhq.app/companies/freenome)
- Location text: Brisbane, California; Onsite
- Where it can be done from (inferred): Onsite · United States (evidence: "Location: Brisbane, California; Onsite")
- Posted: 2026-10-29 (12 days ago)
- First seen by alder: 2026-11-07 · last verified: 2026-11-07
- Reposted: 0 times · edited: 0 times
- Apply on the employer's site: https://job-boards.greenhouse.io/freenome/jobs/8920670002

## Pay and sponsorship

- Posted pay: not posted

## Description (the employer's text)

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.

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Data: alder (https://alderhq.app). Cite https://alderhq.app/jobs/greenhouse%3Afreenome%3A8920670002 and the date you read it. Observed facts come from the employer's own listing; location reach, level, family and skills are inferences.