186522 - Complaint Investigator/Quality Engineer
Industry
PRO
Region
MI-Michigan
City
Kalamazoo
State
MI
Rate
$25 to $30.00 DOE
Duration
6-12 Months
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


Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Zachary Fasano
zfasano@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x252 or (800) 927-9318 x252

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.