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Job Summary

Company
Ware Technology Services
Location
Minnetonka, MN
Job Type
Full Time
Temporary/Contract/Project
Years of Experience
2+ to 5 Years
Education Level
Bachelor's Degree
Career Level
Experienced (Non-Manager)

Quality Engineer

About the Job

Ware Technology Services, your Engineering and IT staffing firm, is looking for a Quality Engineer.
The Quality Engineer will support the divisional quality engineering group. This position will provide quality engineering support to the cross functional Product Development and Process Validation teams. The Quality Engineer develops, practices, and promotes quality principles throughout the organization to achieve defined customer quality requirements and required regulatory compliance. In addition, this individual provides leadership and guidance to the organization to maintain compliance with QSR and ISO certification.
-Provide new product development support.
-Support design verification and validation activities, including sample size determination, data analysis, and protocol and report generation.
-Support the investigation, prioritization and coordination of proposed documentation changes.
-Promote the use of best-practice quality and statistical tools.
-Support with process validation activities, including the development of protocols and reports.
-Provide reliability and failure analysis support.
-Support risk management activities (DFMECA, FTA, pFMEA, etc).
-Coordinate with other quality functions as needed (i.e. Supplier Qualifications, Microbiology, Sterilization, etc).
-Promotes implementation of quality principles at the design and initial manufacturing stage of product development.
 
Requirements:
EDUCATION
-Bachelor's degree in Science, Engineering or equivalent experience
EXPERIENCE
-Minimum of three years medical device and/or drug manufacturing/quality systems.
-Knowledge of process validation, IQ/OQ/PQ.
-Thorough knowledge of QSR and ISO quality systems.
-Strong background in statistical techniques, measurement tools and SPC tools.
-ASQ or other quality related certifications (CQE, CRE, etc) a plus.
SKILLS
-Ability to read and interpret drawings and design specifications.
-Strong technical writing skills.
-Strong verbal communication skills.

Please forward resume to minneapolis@warets.com or mike.koski@warets.com . Visit www.warets.com for more information about opportunities available with Ware Technology Services.

Ware Technology Services, an Atterro Human Capital Group company, offers interim and direct hire staffing for technical positions and executive search services for critical or confidential hires. Ware consultants have proven experience in engineering, design/drafting, skilled technicians, supply chain management, project management, application development and IT infrastructure.




 

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