What are the responsibilities and job description for the Medical Complaint Specialist position at Apex Systems?
The Role :
As a Complaint Specialist, you will ensure compliance to product complaints and the complaint handling system with the responsibility of timely complaint assessment and closure while collaborating with cross-functional teams such as Customer Service, Quality, Engineering, Logistics to facilitate the complaint handling process. In this role, you will :
- Review product complaint information in database, confirm complaint condition to determine necessary action, including CAPA
- Evaluate and investigate potential MDR reportable events to determine if reporting is needed
- Collaborates with cross-functional teams and 3P investigators to ensure additional information is gathered for complaint review / investigations.
- Review complaint against risk matrix and determine if the risk assessment is covering the hazard in the complaint
- Evaluate and track complaints through complaint process workflow to closure
- Prepare ad-hoc reports on needed basis
- Ability to analyze data, looking for trends to summarize and report findings
- Responsible for updating work instructions to capture process changes
- Coordinate and compile team metrics to support monthly team meetings
- Coordinates and prioritizes complaint investigations according to risk
BASIC QUALIFICATIONS :
Preferred Qualifications :