Postmarket Quality Manager

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.

• 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.