Complaints Specialist II Generic Medical Devices
THIS JOB HAS EXPIRED General Description:
The Complaints Specialist II will be responsible for maintain the quality processes associated with complaint handling, procedures and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards. This individual will also obtain adequate information to ensure proper documentation, investigation, and closure of each complaint, in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting. The Complaint Specialist II will ensure all required information is obtained and properly documented to make sound regulatory reporting decisions. In addition, this individual will evaluate all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure. This individual will write customer response letters, as required. This individual will establish reports for the prompt review of new complaints, regulatory reporting decisions, and follow-up. This individual will develop a thorough understanding of the complaint database. Additionally, the Complaint Specialist II will develop, prepare, and analyze trend reports for complaints on a monthly basis or as required. This individual will set up monthly complaint meetings and communicate with worldwide complaint groups, as well as other internal departments including Marketing, R&D, Customer Service and Technical Services. This individual will have a fundamental understanding of basic principles, theories, concepts and techniques related to customer complaints. This individual will investigate and develop solutions to procedure and process related issues. Also, this individual will be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
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.
Maintain complaint database for tracking and trending purposes
Inform executive management and/or design team of product trending and complaints
Maintain complete information for CAPA process, as required.
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 3 to 5 years experience in complaint handling
||2201 34th Avenue NW |
Gig Harbor, WA 98335
THIS JOB HAS EXPIRED