Sr. QE

* Represents the QA function as a core team member on cross functional teams supporting new product development or supports the activities of a quality core team member. * Assesses overall product risk by facilitating the development of risk management tools such as the risk management report, failure mode and effects analyses (FMEAs), etc. * Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required. * Contributes to the successful completion of Process Validation initiatives by facilitating validation master plans and the qualification activities required to meet validation requirements. . * Monitors supplier performance and initiates corrective actions, as required. Develops part qualification plans and supports the production part approval process. Education Required: B.S. degree in Engineering, Math, Physical Science. Minimum Experience: 3 years experience in a regulated industry Skills/Qualifications: * ASQ Certified Quality Engineering (CQE) * Experience with Minitab or similar statistical analysis tools * Experience with Geometric Dimensional and Tolerancing (GD&T) and the ability to read blueprints * Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485 and 14971 requirements

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com