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Education / Educación: Bachelor’s Degree in Engineering or a similar career.
Desirable: Master’s degree
Experience / Experiencia: Minimum of 5 years of experience as a university graduate (bachelor’s degree) in positions with a similar level of responsibility. A medical device process and/or product manufacturing environment is preferred. Recognized expertise within a similar organization in manufacturing process controls and root cause investigations. Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): Experienced with Product and process Control requirements, ISO 13485 and Medical Devices Directive. Experienced with ISO 14971, Risk Management. Ability to effectively work with teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution. Strong ability to assess risks to define appropriate in-process controls, ensure thorough doc...