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Clearning Validation Engineer

Posted on Nov 12, 2018 by Quality Tech Services, LLC

Minneapolis, MN 55420
Engineering
Immediate Start
Annual Salary
Full-Time
Company Overview Quality Tech Services, LLC. is a Cretex Medical Company that is a fast-growing dynamic leader within the Twin Cities medical device industry. QTS offers a technical service to assist medical device OEMs throughout the nation with cleanroom assembly and packaging operations. As an employee at QTS, you'll enjoy a culture founded on teamwork, respectful communication, creative problem solving, dependable follow through and excellent customer service. Ideal Candidate Profile QTS is currently seeking a self-motivated, collaborative Cleaning Validation Engineer to provide the lead technical support for the planning, documentation and execution related to cleaning and passivation process. This includes process development, qualifications and validations for the cleaning equipment and processes. An ideal candidate will have the ability to successfully multi-task, troubleshoot and adapt to change in our fast-paced, dynamic environment. Job Summary Provide engineering support for the Cleaning and passivation validation process and documentation. Includes: Develop and maintain chemical cleaning and passivation process and associated documentation. Research and development of initial cleaning and passivation validation plan for new devices and processes. Prepare validation or performance qualification protocols for new or modified manufacturing processes as required, with an IQ/OQ/PQ approach. Provides price estimates and/or quotations for engineering validation work to sales. Support the maintenance of all chemical baths and equipment throughout the manufacturing facility. Ensure safe working conditions and compliance with environmental and safety regulations. Completes all other work duties as assigned. Skills and Experience Bachelor's Degree in Chemistry, Chemical Engineering, or equivalent education/experience. 1-3 years of experience. Knowledge of cleaning and passivation processes. Familiarity with applicable AAMI, ASTM, and ISO standards related to cleaning. Experience with equipment and process validation. Excellent written and oral communication skills. Ability to work independently with minimal supervision. Ability to work in a fast-paced, team-oriented work environment. Ability to use Microsoft Office (Word/Excel/PowerPoint) and ERP and other business related systems. For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

Reference: 569501050