Complaint Coordinator

Category:

QC

Employment Type:

Contract

Reference:

BH-377724

Yoh
has a contract opportunity for a Complaint Coordinator
role with our client for a Onsite opportunity in Gainesville, FL.

• 2-Months (with the possibility of extension)
• Pay Rate: $25.00 - $32.00/hr DOE.
• 100% Onsite

• 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 company Quality System and any appropriate federal and international standards
• Assisting and supporting other employees, teams, and sales personnel as necessary
• Practicing company Values

• 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
  
• 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.
• Actively participating as a member of a team to move the team toward the completion of goals.
• Developing and using collaborative relationships to facilitate the accomplishment of work goals.
• Taking prompt action to accomplish objectives; taking action to achieve goals beyond what is required; being proactive.
• 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 consequence
  
• Establishing courses of action for self and others to ensure that work is completed efficiently.
• Working in a conscientious, consistent and thorough manner. Demonstrates concern for thoroughness and accuracy
• 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.