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QA Complaint Specialist Associate

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 06/11/2019 Job Type: Scientific Job Number: JN -062019-25062
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 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

Qualifications:
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
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.
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