Postmarket Quality Manager

The role

This person will own the end-to-end complaint handling and CAPA programs. They will mentor junior team members and serve as the Quality interface for commercial partners.

What you will do

• Own the end-to-end complaint handling process.
• Own the CAPA program.
• Serve as the escalation point and technical mentor for junior team members.
• Serve as the primary Quality liaison to commercial partners and customer-facing teams.
• Monitor and analyze complaint, CAPA, and non-conformance trends.
• Compile and present quality signals data for management review.
• Participate in change control reviews and risk evaluations.
• Escalate issues to Quality leadership and serve as the Quality delegate in audits or inspections.

Required qualifications

• 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 have

• 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

• Equity
• Cash bonuses
• Medical benefits
• Financial benefits
• Other benefits

About the company

Freenome is approaching FDA approval and commercial launch of SimpleScreen, its cfDNA-based colorectal cancer detection test.