Complaint Coordinator

4 weeks ago


Gainesville, Florida, United States Yoh Full time
Job Summary

The Complaint Coordinator will be responsible for coordinating complaint handling activities to ensure regulatory compliance and customer satisfaction. This role requires strong organizational and communication skills, as well as the ability to work effectively in a team environment.

Key Responsibilities
  • Coordinate the receipt, documentation, investigation, and resolution of customer complaints to ensure regulatory compliance and customer satisfaction.
  • Ensure compliance with federal and international medical device adverse event and incident reporting requirements.
  • Facilitate product correction and removals to ensure regulatory compliance and patient safety.
  • Provide training to employees, sales agents, and customers on regulatory requirements for complaint handling, adverse event reporting, corrections, and removals.
  • Apply company Quality System and federal and international standards.
  • Assist and support other employees, teams, and sales personnel as necessary.
Requirements
  • High School Diploma or GED required. Associate and/or bachelor's degree from an accredited institution preferred.
  • Minimum 1 year experience in document control or record maintenance systems is preferred.
  • Minimum 1 year of experience in complaint handling, adverse event reporting, and correcting and removals is preferred.
  • Experience with FDA/ISO quality management system regulations preferred.
  • Working knowledge of Windows-based office productivity tools.
  • Experience with quality system management software a plus.


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