14343763
Located in Gainesville, FL
Pay: 29.00
Job Full Description
Complaint Coordinator (29.00/hr, 2 month duration with opportunity for extension)
The purpose of the Complaint Coordinator is to coordinate complaint handling activities to ensure regulatory compliance and customer satisfaction. Position will work Monday - Friday 8am to 5pm. Position will be for at least 2 months with a very high likelihood of further contract extension. High performance in the role can also lead to evaluation for permanent hire.
Duties and Responsibilities:
1. Coordinating the receipt, documentation, investigation and resolution of customer complaints to ensure regulatory compliance (e.g., FDA, CMDR, ISO) and customer satisfaction
2. Ensuring compliance with federal and international medical device adverse event and incident reporting (MDR/MDV/Health Canada) requirements
3. Facilitating product correction and removals (recalls, market withdrawals and stock retrievals) to ensure regulatory compliance and patient safety
4. Providing training to employees, sales agents, sales representatives and customers regarding the regulatory requirements for complaint handling, adverse event reporting, corrections and removals, and corrective and preventive actions
Education:
High School Diploma or GED required. Associate and/or bachelor’s degree from an accredited institution preferred
Experience:
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
Functional/Technical Knowledge, Skills and Abilities:
Working knowledge of windows based office productivity tools
Experience with quality system management software
Gainsville, FL
2622
4400 Northwest 36th Avenue
Gainesville, FL 32606
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