Customer Complaints Specialist Zeltiq Aesthetics, Inc.
The primary responsibility of this position is the investigation, analysis, resolution, trending and corrective action of all complaints.
Specific responsibilities include; maintaining the complaint files and supporting the resolution of complaint CAPAs to closure and verification of CAPA effectiveness.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
? Day-to-day review of service calls to identify and categorize complaints
? Establishes and maintains complete complaint files for all customer complaints
? Responsible for investigating complaints to resolve both product/procedure issues determined through failure analysis, focusing on root cause analysis
? Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
? Interfaces with customer service and technical service and other groups on a daily basis to drive timely completion of complaints
? May communicate directly with customer to resolve complaints
? Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving complaints
? Maintains compliance to internal complaints procedure, FDA, ISO and Canadian medical device regulations
? Bachelors degree in science or other technical discipline preferred or a minimum of 3 years relevant work experience
? Minimum of 2 years of experience in FDA regulated medical device manufacturing environment(s). Knowledge of QSR, 13485:2003, and 14971:2007
? Problem solver
? Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook
? Responsible for performing all duties in compliance with FDA?s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
||Pleasanton, CA |