Medical Device Complaint Specialist
A company is looking for a Complaint Evaluation Specialist-Medical Device.
Key ResponsibilitiesTrack 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 auditsRequired QualificationsBachelor'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