Purpose:
The purpose of the Complaint Coordinator is to coordinate complaint handling activities to ensure regulatory compliance and customer satisfaction.
Duties and Responsibilities (Key Deliverables):
- Coordinating the receipt, documentation, investigation and resolution of customer complaints to ensure regulatory compliance (e.g., FDA, CMDR, ISO) and customer satisfaction
- Ensuring compliance with federal and international medical device adverse event and incident reporting (MDR/MDV/Health Canada) requirements
- Facilitating product correction and removals (recalls, market withdrawals and stock retrievals) to ensure regulatory compliance and patient safety
- 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
- Knowing and applying Client’s Quality System and any appropriate federal and international standards
- Assisting and supporting other employees, teams, and sales personnel as necessary
- Practicing Client’s Values
JobRequirements:
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 preferred
Functional/Technical Knowledge, Skills and Abilities Required:
- Working knowledge of windows based office productivity tools
- Experience with quality system management software a plus
Work Standards:
- Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks; self-imposing standards of excellence rather than having standards imposed.
Contributing to Team Success:
- Actively participating as a member of a team to move the team toward the completion of goals.
Building Strategic Work Relationships:
- Developing and using collaborative relationships to facilitate the accomplishment of work goals.
Initiating Action:
- Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.
Decision Making:
- Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
Planning and Organizing:
- Establishing courses of action for self and others to ensure that work is completed efficiently.
Attention to Detail:
- Working in a conscientious, consistent and thorough manner. Demonstrates concern for thoroughness and accuracy
Communication:
- Clearly conveying information and ideas through a variety of media to individual or groups in a manner that engages the audience and helps them understand and retain the message.
