Position Purpose: Complaint Handling
Process customer complaints for device reportability to FDA
Assess customer complaints for FDA reportability using the MDR Decision Tree
Create MedWatch forms for FDA submission of MDRs
Perform related duties as assigned.
Strong communication and interpersonal skills
Solid analytical skills and the demonstrated ability to solve problems quickly and creatively
Strong organization skills and good attention to detail
Self-directed individual, with excellent follow through
Ability to work well within a team environment
Solid computer skills, including proficiency in MS Office suite
Currently enrolled as a Sophomore, Junior, or Senior in Quality Assurance/Regulatory, or related field with a 3.0/4.0 GPA or better
Prior related work experience preferred, but not required
Direct exposure to health and safety hazards associated with production materials and equipment
Training relative to Company requirements and procedures and individual job duties will be provided as outlined on the Training Requirements form. A training file containing documentation of all training received is maintained for each employee.
Job descriptions change from time to time. The Company retains the right at its sole discretion to modify, delete, or add to any of the information contained in this document.