Complaints Specialist I Generic Medical Devices
THIS JOB HAS EXPIRED General Description:
The Complaints Specialist is responsible for input, investigation and closure of complaints. Including, but not limited to input all customer information, details of incident, and review each complaint for reporting criteria to National Authority or FDA. Ensure all required information is obtained to assure proper documentation and investigation of complaint. Complaint Specialist is required to understand worldwide reporting requirements, as well as complaint handling knowledge in order to meet international standards.
Key Duties And Responsibilites:
Assist in managing and coordinating the investigation of complaints.
Prepares Complaint files.
Prepares MDR and Vigilance reports if necessary
Maintain proper communication and documentation with Notified Bodies
Evaluate all information for clinical and technical perspective to ensure proper analysis, investigation root cause and quality engineering review is documented prior to complaint closure.
No direct supervisory responsibilities
Minimum Requirements And Qualifications:
Microsoft office product familiarity preferably Vista
Excellent customer service skills
Familiar with MS Project and Access
Outstanding verbal and written skills
Ability to prioritize multiple projects
Familiar with ISO 13485, MDR, MDV and Canadian regulations
Ability to work as a team member, as well as individually
Minimum Bachelors Degree
1 to 3 years experience in Complaint Handling
||2201 34th Avenue NW |
Gig Harbor, WA 98335
THIS JOB HAS EXPIRED