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QA Complaint Specialist Associate

Oakland-Fremont-Pleasanton Metro Area, CA

Job Type: Scientific Job Number: JN -012020-26264 Region: Oakland-Fremont-Pleasanton Metro Area

Job Description


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.

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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