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