Job Listing Description

Complaint Investigator/Quality Engineer

Description:
Chipton-Ross is seeking a Complaint Investigator/Quality Engineer for an opening in Kalamazoo, MI.

RESPONSIBILITIES:
This position coordinates the customer complaint handling and investigation process, providing a key interface between the Customer and the QA/Operations/Engineering complaint investigation teams. This position also supports investigation and closure of internal and external non-conformances.
" Responsible for the initial QA review of customer complaints and requesting information/facts from Customer or the Distributor as required.
" Responsible for the customer complaint handling process, including logging complaints and performing assessments to determine potential reportability.
" Responsible for the maintenance of data and reporting of key trends in the electronic complaint handling system.
" Responsible for monitoring the progress of complaint handling and investigation, and working with applicable individuals and departments to ensure complaint handling time requirements are met.
" Responsible for tracking and trending complaints and preparing complaint analysis reports, highlighting any adverse trends.
" Responsible for highlighting any potential reportable events to QA and/or RA Management as soon as possible as per the Medical Device Reporting/Vigilance procedures.
" Responsible for preparing & presenting data/reports regarding complaint metrics for submission to site and Corporate Management Review.
" Responsible for planning & performing non-conformance investigations. This may include coordinating the return of parts involved in investigations back to the factory for further investigation.
" Responsible for contributing to the continual quality & reliability improvement of company products.
" Maintain working relationships with company-wide strategic partners and third party organizations.
" Ensure policies, procedures and practices are in compliance with global quality & regulatory requirements and meet the needs of our customers & Quality Policy.
" Responsible for performing tasks to support the quality system and quality policy as directed by QA management.

REQUIRED EXPERIENCE:
" Experience working with FDA regulated products (Medical Device/IVD preferred)
(pharmaceutical or dietary supplement experience is acceptable)
" Knowledge of ISO13485 / FDA QSR Part 820 / 803 requirements preferred
" Experience working with complaint handling
" Knowledge of statistical data analysis tools and techniques
" Excellent interpersonal skills
" Ability to work in a timeline driven environment
" Excellent communication skills both written & oral
" Excellent computer skills, particularly spreadsheets/graphical software tools (e.g. Excel)

EDUCATION:
Accredited Associate or Bachelor's Degree required

WORK HOURS:
M-F; 1st Shift (8:00am-4:30pm)
Full-Time


 
Job Number: 186522
Job Location: Kalamazoo, MI
Rate: $25 to $30.00 DOE
Duration: 6-12 Months
Input Date: 07/15/2020
Last Updated: 08/10/2020
Firm Name: CHIPTON ROSS
Attention: Zachary Fasano
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: zfasano@chiptonross.com
Website: www.chiptonross.com

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