# Postmarket Quality Manager

**Company**: Freenome
**Location**: Brisbane, California
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Salary**: $134,425 - $170,100
**Category**: Other
**Industry**: Healthcare

**Apply**: https://job-boards.greenhouse.io/freenome/jobs/8920670002?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_1d9fcf3d-08a

## Description

Freenome is seeking a Postmarket Quality Manager to oversee the postmarket quality infrastructure for its commercial launch. The successful candidate will build and run a complaint handling program that meets regulatory requirements across two distinct environments. They will also own the CAPA program, ensuring that complaints and quality events drive corrective action.

Responsibilities:

- Own the end-to-end complaint handling process, applying distinct regulatory requirements for CAP/CLIA laboratory quality events and IVD postmarket complaints under 21 CFR 820/QMSR and ISO 13485.

- Own the CAPA program, ensuring rigorous corrective action with documented root cause analysis, implementation, and effectiveness verification.

- Serve as the escalation point and technical mentor for junior team members managing non-conformances and laboratory incidents.

- Interface with commercial partners and customer-facing teams to capture, evaluate, and act on partner- and customer-reported feedback and complaints.

- Monitor and analyze complaint, CAPA, and non-conformance trends; identify systemic issues and escalate with supporting analysis and recommended corrective actions.

- Compile and present quality signals data for management review and postmarket surveillance reporting.

- Participate in change control reviews and risk evaluations as the postmarket quality representative.

Requirements:

- 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.

- 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.

- 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.

- Proficiency with an electronic QMS (eQMS) platform.

Nice to haves:

- Hands-on experience with CAP LAP inspections 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.

- 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:

- The US target range of base salary for new hires is $134,425 - $170,100.

- Eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits.

## Skills

### Required
- CAP/CLIA
- IVD
- QMSR
- ISO 13485
- CAPA
- Complaint Handling
- Root Cause Analysis
- Corrective Action
- Technical Writing
- eQMS

### Nice to have
- CAP LAP inspections
- NYSDOH Part 58
- Molecular Diagnostics
- cfDNA
- NGS
- MDR evaluation
- ASQ CQA

---

Source: [Apply at job-boards.greenhouse.io](https://job-boards.greenhouse.io/freenome/jobs/8920670002?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)