PS-Professional Services

Employment TYPE

Contract

LOCATION

Pleasanton, California

DATE POSTED

April 10, 2019

INDUSTRY

PS-Professional Services

POSITION(S)

1

SALARY

Negotiable

Job# J467

QA COMPLAINT SPECIALIST ASSOCIATE

About The Opportunity

Job 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.
  • 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

Required Skills

    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.

Duration

8 Months

Please Contact me to discuss the hiring process!

Harmanpreet Singh

Sr. Executive Recruiter
Contact: (310) 929-8421 Ext: 108
Email: harman.s@staffactory.com

Hi! My name is Harmanpreet Singh. I love to work with people and help them find their dream job. I work with my consultants to understand their niche area of work and look for the best match for them. I feel that keeping in mind the priorities of my consultants help me to serve them better. Additionally, I always keep them posted about new relevant jobs which help me to build a connection with them not only professionally but at a personal level as well.