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QA Complaint Specialist Associate

Company:
LanceSoft Inc.
Location:
Pleasanton, California, United States
Posted:
April 10, 2019

Description:

Title: QA Complaint Specialist Associate

Location: Pleasanton, CA

Description:

• The primary responsibility of this position is the investigation, analysis, resolution, trending and corrective action of all complaints. Specific responsibilities include; maintaining the complaint files and supporting the resolution of complaint CAPAs to closure and verification of CAPA effectiveness

• 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