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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)
 
Summary
  • 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
Qualifications
  • 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. 
Contact
Abdul. A
Direct: (732) 272 0298 | Email: Abdul.A@sunrisesys.com
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com