Lead Complaint Specialist
Role: Lead Complaint Specialist
Salary: $100k-$115k
Location: 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 13485
- Experience 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 Responsibilities
Complaint Handling
- Own the complaint handling process from intake through closure in accordance with 21 CFR 820.198 and ISO 13485
- Perform complaint intake, documentation, and triage ensuring complete and accurate records
- Lead complaint investigations including root cause analysis and trend identification
- Assess reportability and support MDR / vigilance determinations in partnership with Regulatory Affairs
- Ensure timely closure of complaints in compliance with KPIs and regulatory expectations
- Maintain complaint files in an audit-ready state
- CAPA & Quality System Support
- Support and/or lead CAPAs arising from complaints, audits, or internal findings
- Assist with nonconformance investigations and root cause analysis
- Support quality system process improvements and procedure updates
- Provide audit support including inspections and documentation readiness
- Cross-Functional Collaboration
- Partner with Quality Engineering, Operations, and R&D on investigations and corrective actions
- Work with Regulatory Affairs on MDRs and reportability assessments
- Coordinate with field and clinical teams for complaint intake and follow-up
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