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Quality Systems Manager - Contract Medical Device

Kimball Electronics - Indianapolis, IN
Indianapolis, Indiana, United States
November 28, 2016

Quality Systems Manager

Are you a highly motivated individual looking for an ever changing, fast paced environment, with the freedom to make changes and drive improvements? If so, this is the job for you! We are a medical device contract manufacturer that is a part of a multinational EMS company and we’re looking for a Quality System Manager to support our Quality Management System (QMS). This role requires staying abreast of and communicating regulation updates as well as administering our company’s QMS and associated procedures. We are a publicly traded company with lots of strong opportunity for growth.

Position Overview

Our Quality System Manager responsibilities include:

•Serving as a backup Management Representative for audits/inspection

•Maintaining communication with certification bodies

•Staying abreast of changes to QMS standards, ISO13485 and 21 CFR parts 820, 4, 11, 210 & 211

•Providing direction and support to personnel regarding new/revised standards and regulations

•Facilitating the development and implementation of QMS improvements

•Assisting personnel with QMS issues

•Communicating QMS issues to management

•Supporting compliance to the Safety and Environmental policies and programs

•Aiding in setting priorities and participating in Lean Six Sigma initiatives and projects

Basic Background Requirements

•Successfully interview with relevant hiring team

•Successfully pass pre-employment drug test

•Previous Quality System experience of 5 years required

Strong QMS standards knowledge

Strong auditing skills

Strong computer skills

Strong written and grammar skills

Strong reading comprehension skills

Qualified to perform audits for ISO 13485 and 21 CFR Part 820

•Bachelor’s Degree is preferred, however, relevant experience may be substituted

Key Performance Objectives

Week 1:

•Complete required HR, Safety, Quality, and Benefits Orientation

•Complete company QSP training

Week 2 –6 months

•Begin On-The-Job-Training

•Assist Quality Manager with Quality improvement initiatives

•Get familiar with manufactured products and processes

•Drive improvement to internal QMS audit program

•Manage current established plan for QMS improvement

6 months +

•Complete Yellow Belt training

•Expand knowledge/training of both Starrett and Hexagon CMMs

•Participate in Lean Six Sigma initiatives and projects

•Drive continuous QMS system improvement related to efficiency

•Stay abreast of changes to QMS standards, ISO13485 and 21 CFR parts 820, 4, 11, 210 & 211

Kimball Electronics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, disability or protected veteran status.