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Quality Systems Engineer - Eden Prairie, MN
Ware has partnered with a medical device company that is in need of a contract Quality Systems Engineer. Our client is looking to get someone started right away!
Lead the development and maintenance of a robust quality system in compliance with all relevant standards and regulations. Create and deploy quality system processes in support of corporate objectives. Serve as subject matter on and lead internal audit program. Directly involved in shaping strategies that will support on-going improvement and effectiveness of the quality system.
Initiate, facilitate and/or manage projects to expand, change, enhance and improve the quality system, as assigned through the QMS integration project
Bachelor degree or Master degree in Engineering.
7 years Quality Systems experience
Demonstrated expertise and hands-on experience with FDA regulations, FDA QSR, ISO 13485:2016, Medical Device Regulation, and other national and international regulations (MDSAP, etc.).
Ability to respond to inquiries from customers, regulatory agencies, or members of the business community.
Strong written and verbal communication skills and interpersonal skills to effectively translate ideas, concepts and information clearly and concisely.
Demonstrated project management skills in order to plan, conduct and implement system assessments.
Experience with QMS integration project and working cross-functionally to drive project completion
EQUAL OPPORTUNITY EMPLOYER
The Company supports affirmative action and equal employment opportunity. The Company will provide equal employment in employment practices to all applicants for employment. Employment decisions shall be made without regard to any protected characteristic such as, but not limited to, race, color, religion, gender, age, disability, national origin, ancestry, citizen status, gender identity, sexual orientation, marital status, status in regard to public assistance, disabled veterans, recently separated veterans, Armed Forces service medal veterans and other protected veterans, genetic information and other legally protected classes. Furthermore, the Company is an E-Verify employer. Information provided on this application will not be used for any discriminatory purposes. The Company complies with all applicable federal, state and local non-discrimination laws and regulations. The Company will provide reasonable accommodations in the application or interviewing process. If you need a reasonable accommodation in the application or interviewing process, please contact us.
Eden Prairie, MN
United States of America
Engineering / Engineering
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Job Title: Quality Systems Engineer
Location: Eden Prairie, MN
Job Type: Temp Position
Reference ID: 349104
Posted Date: 12/5/2018