Lead Complaint Specialist

Role: Lead Complaint SpecialistSalary: $100k-$115kLocation: Aliso Viejo, CA JD: The Lead Complaints Specialist is responsible for owning the end-to-end complaint handling process while supporting broader quality system activities as a generalist. This role ensures timely, compliant intake, investigation, and closure of complaints in accordance with FDA, ISO, and internal requirements. In addition, the role provides support across CAPA, nonconformances, audits, and quality system processes to help scale and strengthen the organization's overall quality function.Qualifications:Bachelors in scientific or technical field or equivalent experience 5+ years of med device experience with direct complaint handling Strong knowledge of FDA 21 CFR Part 820 and ISO 13485Experience with root cause investigations and CAPA Preferred:Experience supporting MDR reporting or global vigilance Experience with audits or FDA inspections Experience with Class II or III devices Key ResponsibilitiesComplaint Handling Own the complaint handling process from intake through closure in accordance with 21 CFR 820.198 and ISO 13485Perform complaint intake, documentation, and triage ensuring complete and accurate recordsLead complaint investigations including root cause analysis and trend identificationAssess reportability and support MDR / vigilance determinations in partnership with Regulatory AffairsEnsure timely closure of complaints in compliance with KPIs and regulatory expectationsMaintain complaint files in an audit-ready stateCAPA & Quality System Support Support and/or lead CAPAs arising from complaints, audits, or internal findingsAssist with nonconformance investigations and root cause analysisSupport quality system process improvements and procedure updatesProvide audit support including inspections and documentation readinessCross-Functional CollaborationPartner with Quality Engineering, Operations, and R&D on investigations and corrective actionsWork with Regulatory Affairs on MDRs and reportability assessmentsCoordinate with field and clinical teams for complaint intake and follow-up