Complaint Determination Associate

Job Summary

A company is looking for a Complaints Handler to manage the complaint determination process for medical devices.

Key Responsibilities

• Review and execute the process to determine if an inquiry record qualifies as a medical device complaint
• Assign complaint cases and non-complaint feedback to appropriate categories for better processing and reporting
• Reassess inquiry records based on new information and perform additional complaint handling tasks as needed

Required Qualifications

• Experience in medical device complaint handling or a related field preferred
• Solid understanding of QSR and/or ISO 13485 preferred
• Demonstrated knowledge of MS Office
• Working knowledge of complaint handling functions in a medical device company preferred
• Familiarity with TrackWise and SalesForce CRM preferred