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QA Complaint Specialist Associate

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 10/25/2019 Job Type: Scientific Job Number: JN -102019-25878

Job Description

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


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.

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