Medical Device Complaint Specialist

Job Summary

A company is looking for a Complaint Evaluation Specialist-Medical Device.

Key Responsibilities

• Track all stages of the Complaint Documentation process including reportability determination, data analysis, reporting, and trending
• Review and analyze lot documentation to identify anomalies and maintain accurate documentation related to complaints and special projects
• Train team members on complaint coordination processes and assist during FDA, ISO, or internal audits

Required Qualifications

• Bachelor's degree or 3+ years of experience in medical device complaint evaluation or vigilance reporting
• 1-2 years of experience in data management and record keeping
• Experience in troubleshooting within the medical device or related field
• Knowledge of FDA and ISO regulations is preferred
• Proficiency in MS Office and database systems