Lead Medical Device Complaints & CAPA Specialist

EPM Scientific; Aliso Viejo (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

EPM Scientific is seeking a Lead Complaints Specialist to own end-to-end complaint handling and support broader quality system activities across CAPA and nonconformances. The role ensures timely intake, robust investigations, and closure of complaints per FDA/ISO requirements in a fast-paced med device environment.

Responsibilities include leading investigations, triaging records, ensuring audit-ready files, and collaborating with Regulatory Affairs and cross-functional teams for MDRs and

Qualifications

• Bachelor's degree or equivalent experience in a scientific/technical field is required.
• Minimum 5+ years in medical device complaints handling.
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with root cause investigations and CAPA.

Responsibilities

• Own the complaint handling process from intake through closure in alignment 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 with Regulatory Affairs.
• Ensure timely closure of complaints in compliance with KPIs and regulatory expectations.
• Maintain complaint files in an audit-ready state.
• Support CAPA & Quality System activities and improvements.
• Assist with nonconformance investigations and root cause analysis.
• Coordinate with Regulatory Affairs on MDRs and reportability assessments.
• Collaborate with field and clinical teams for complaint intake and follow-up.

Skills

Med device complaint handling

FDA 21 CFR Part 820 knowledge

ISO 13485 knowledge

Root cause investigations

CAPA

Education

Bachelor's degree in scientific or technical field or equivalent experience

Job description

EPM Scientific is seeking a Lead Complaints Specialist to own end-to-end complaint handling and support broader quality system activities across CAPA and nonconformances. The role ensures timely intake, robust investigations, and closure of complaints per FDA/ISO requirements in a fast-paced med device environment.

Responsibilities include leading investigations, triaging records, ensuring audit-ready files, and collaborating with Regulatory Affairs and cross-functional teams for MDRs and