Lead Complaint Specialist
Role: Lead Complaint Specialist
Salary: $100k - $115k
Location: Irvine, CA (On-site)
EPM is partnered with a growing medical device company in Orange County that's building out its Quality function and looking to bring in a Lead Complaint Specialist. This is a high-impact role owning the complaint handling process end-to-end, while also contributing across CAPA and broader QMS activities as the team scales.
Key Responsibilities:
- Own complaint handling from intake through closure, ensuring compliance with FDA (21 CFR 820.198) and ISO 13485 requirements
- Lead investigations, including root cause analysis, trend identification, and reportability assessments (MDR/vigilance support)
- Maintain audit-ready complaint files and drive timely closure aligned with KPIs and regulatory expectations
- Support CAPAs, nonconformance investigations, and broader quality system improvements
- Partner cross-functionally with QA/RA, Engineering, Operations, and Clinical teams on investigations and corrective actions
Qualifications:
- Bachelor's degree in a scientific/technical field or equivalent experience
- 5+ years in medical devices with direct complaint handling ownership
- Strong working knowledge of FDA 21 CFR Part 820 and ISO 13485
- Hands-on experience with root cause investigations and CAPA processes
- MDR reporting, audits/inspections
Benefits:
- Competitive compensation
- Bonus
- Medical, vision, dental
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