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: 20-02535
Location: Pleasanton, CA 94588
Duration: 12 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; while maintaining the complaint files.
· Essential Duties and Responsibilities include the following (other duties may be assigned.):
· Being point of contact with customers and patients.
· Providing excellent customer service and guiding customers and patients through complaint reporting process.
· 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
· Will 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
· 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.
· 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.
Direct: 732-272-0278 | Email: email@example.com
Direct: (732) 272 0265 | Michael@sunrisesys.com