Post Market Complaints Specialist

Job Summary

Seeking an experienced Post Market Complaints Specialist, the remote contract position will manage complaint handling and post-market surveillance activities for medical devices, focusing on investigations, root cause analysis, and compliance with FDA and ISO standards.

Key Responsibilities

• Review, evaluate, and process customer complaints for medical devices
• Perform complaint investigations to determine root cause, product impact, and reportability
• Document complaint records using quality management systems and support Health Hazard Evaluations and risk assessments

Required Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or a related field
• 3-7+ years of experience in Complaint Handling, Post Market Surveillance, or Quality Assurance within the Medical Device industry
• Experience investigating complaints for Class I, II, or III medical devices
• Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and Medical Device Reporting (MDR)
• Experience with CAPA, Nonconformance, Root Cause Analysis, and Risk Management