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Responsible for assisting in the implementation and monitoring of customer product complaints. This position is responsible for reviewing and processing the customer product complaint record, ensuring documentation compliance to established and formalized procedures. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Normally receives general instructions on routine work assignments, detailed instructions on new assignments. Can perform work assignments independently with minimum supervision.
Job Responsibility:
Requires considerable computer data entry
Reviews and processes customer product complaints daily
Reviews data between multiple databases and exported spreadsheets
Interface with multiple functions and departments
Performing tasks, of moderate complexity, within planned schedules and timelines
Contributes to the completion of milestones associated with specific projects
Ensures discrepancies are corrected and properly documented in the complaint quality record as well as monitoring systems (example: SharePoint or excel)
Interacts effectively in various levels of the organization
Verifies work done by peers
Provides guidance to Associates or other functions to ensure compliance to Quality System Requirements
Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements
Participates as required in training on regulatory issues affecting own area of work
Brings regulatory compliance questions/issues to the attention of management
Follows establish BDB procedures assigned in their training system
Participates in problem solving as needed
Reports quality issues to Manager, QA
Can work effectively in multiple complaint management systems
Performs other related duties and assignments as required
Requirements:
A minimum of a College Degree
A minimum of 1 year experience in a medical device environment
A minimum of 1 year experience in customer product complaints
Analytic Skills
Must be able to multitask
Must be able to communicate effectively in written and presentation form