Coordinate the receipt, documentation, investigation, and resolution of customer complaints to ensure compliance with FDA, CMDR, and ISO regulations and meet customer satisfaction standards.
Coordinate the receipt, documentation, investigation, and resolution of customer complaints to ensure compliance with FDA, CMDR, and ISO regulations and meet customer satisfaction standards.
Ensure adherence to federal and international requirements for adverse event and incident reporting (MDR, MDV, Health Canada).
Facilitate product corrections, recalls, market withdrawals, and stock retrievals to maintain regulatory compliance and prioritize patient safety.
Provide training to employees, sales agents, sales representatives, and customers on complaint handling, adverse event reporting, corrective actions, and product recalls.
Maintain and apply knowledge of company's Quality System, federal standards, and relevant international regulations.
Assist and support other employees, teams, and sales personnel as necessary to promote efficient complaint handling and regulatory adherence.
Skills Required
Working knowledge of Windows-based office productivity tools (e.g., Microsoft Word, Excel).
Experience with quality system management software is an advantage.
Set and maintain high standards for self and others, demonstrating accountability for completing tasks with excellence.
Actively participate in team efforts to achieve goals, contributing positively to team success.
Take proactive steps to accomplish objectives and go beyond what is required to achieve goals.
Analyze data, identify issues and make informed decisions using available facts and constraints
Develop efficient plans and actions to ensure tasks and goals are achieved in a timely manner
Demonstrate thoroughness and accuracy in all tasks, ensuring precision in complaint documentation and reporting
Clearly convey information and ideas to individuals or groups through various channels, ensuring understanding and retention of the message.
Build and maintain collaborative relationships to accomplish work goals effectively.
Education/Training/Certifications
High School Diploma or GED required.
Associate or Bachelor's degree from an accredited institution preferred.
Additional Requirements
Minimum of 1 year of experience in document control or record maintenance systems preferred.
Minimum of 1 year of experience in complaint handling, adverse event reporting, and product corrections or removals preferred.
Experience with FDA and ISO quality management system regulations is a plus.
We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.