Complaint Coordinator Globus Medical

Description

As a Complaint Coordinator (CC) your responsibilities will be to work with Customer Service, Sales, and any complainant in order to document complaints and initiate the complaint investigations. The CC will also ensure all complaints and returned product complaints have complete information, will perform analysis of returns ID, Device History Record (DHR) review, and review of previous complaint records. The CC also reviews all applicable reports/data and performs trend analysis. Must possess strong skills in the areas of verbal and written communications, interpersonal relationships, and analysis of data.

Primary Responsibilities:

Administer the Product Complaint program by making entries into the Complaint log and review return products before submission to Product Development Engineering including the analysis of returns for correct ID, performing Device History Record (DHR) and previous complaint record search for similar failure modes.
Handle MDR Processing, gather patient /surgery information, and input information into Fillable MedWatch Form.
Work with Customer Service, Sales, and complainants in order to assure all returned product complaints have complete information.
Assist in reviewing Non-Conforming Reports and Complaint Evaluation forms for trend analysis and CAPA program.
Handle miscellaneous duties as necessary in the performance of the process and the quality assurance department.

Qualifications

Working knowledge of Microsoft Office applications, ACCESS, and Excel, to help administer the analysis programs and to perform standard operation procedural (SOP) changes.
Good problem solving and analytical skills working in an independent environment while handling QA tasks.
Must be able to interact and effectively communicate with all levels of employees and external customer / sales individuals.
Knowledge of FDA regulations and ISO standards is preferred.
Background in Medical Device and/or Quality Assurance is preferred.
Bachelors Degree preferred
2+ years experience in a customer service oriented role.
Must be able to lift up to 50lbs.

Location:	Valley Forge Business Center 2560 General Armistead Avenue Audubon, PA 19403 United States