Lead Complaint Specialist

EPM Scientific; Aliso Viejo (CA); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Med device complaint handling

FDA 21 CFR Part 820 knowledge

ISO 13485 knowledge

Root cause investigations

CAPA

Formation

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

Description du poste

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

• 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