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QA Complaint Specialist Associate

Global Channel Management, Inc.
Pleasanton, California, United States
April 10, 2019

Posted By Premium Recruiter


QA Complaint Specialist Associate needs 1 year of experience in FDA regulated medical device manufacturing environment

QA Complaint Specialist Associate requires:

Knowledge of QSR, ISO13485, and ISO14971

Bachelors degree in science or other technical discipline or

a minimum of 2 years relevant work experience

QA Complaint Specialist Associate duties:

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

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