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22 days old

Quality System Specialist

Kelly Services
Ann Arbor, MI 48104
**Kelly Science has an exciting opportunity for a Quality System Specialist in Medical Devices/ Pharma located in Ann Arbor, MI!**



We are seeking a Quality System Specialist to support all core quality system processes including but not limited to, Document Control, CAPA, Nonconforming Events, and Internal Auditing.

The Quality System Specialist works closely with site leaders to support and lead them through each of these main processes.

Performs quality systems compliance support for various quality improvement initiatives.

Assists with the reporting of quality process metrics such as monthly KPIs for Quality Objective tracking and management review.


Job Responsibilities


Other duties may be assigned, in addition to those identified below.

Performs all duties in compliance with FDA, CAP/CLIA, OSHA and other regulatory requirements.

Oversees the document change management life-cycle process in Greenlight Guru.

Maintains original and authorized copies of quality system documents, or other components of the quality system. Maintain all records in an accurate and orderly condition and readily available for review or audit by authorized personnel. These records include: Device Master Record and components, product and component specifications, Change Orders (COs) and any other files or records which QA management may designate.

Oversees the daily management of the QMS training program, including the preparation of training rosters, deployments in Greenlight Guru, and communication of Manages the day to day training

Other duties as assigned.


Qualifications


Required Knowledge:

Associate Degree in Business or 1-3 years equivalent experience with quality system compliance.

Knowledge of GMP/ISO/CAP/CLIA requirements relating to a Medical Device Manufacturer and/or Clinical Laboratory

Required Skills:

Excellent verbal and written communication skills. Excellent office skills with high attention to detail and accuracy. Ability to manage multiple tasks and to work independently as a self-starter.





**Interested? Apply Now!**




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-10-02 Expires: 2020-11-21

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Quality System Specialist

Kelly Services
Ann Arbor, MI 48104

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