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QA Complaint Specialist Associate
Ref No.: 19-09286
Location: Pleasanton, California
Sunrise System Inc. is currently looking for QA Complaint Specialist Associate in Pleasanton, CA with one of our top client.
Job Title: QA Complaint Specialist Associate
Job Id: 19-09286
Location: Pleasanton, CA 94588
Duration: 7 months
Position Type: Hourly contract Position (W2 only)
  • 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 complaint
  • 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
  • Bachelor’s 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
  • Problem solver.
  • Self-directed.
  • Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Additional Requirements
  • 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. 
Abdul. A
Direct: (732) 272 0298 | Email:
Michael Peng
Direct: (732) 272 0265 |