QA Complaint Specialist Associate
Oakland-Fremont-Pleasanton Metro Area, CA
The primary responsibility of this position is the investigation, analysis, resolution, trending of all complaints. Specific responsibilities include; maintaining the complaint files and providing excellent customer service.
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 or a minimum of 2 years relevant work experience preferred
Minimum of 1 year of experience in FDA regulated medical device manufacturing environment(s) preferred
Knowledge of QSR, ISO13485, and ISO14971
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.