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Validation Engineer
Validation Engineer is required to support Validation/Qualification activities in a Medical Devices manufacturing environment.
Requisitos: Requirements: -Bachelor Degree in Engineering Field (Mechanical, Electrical, Industrial Engineers preferred).? -Knowledge in 21 CFR Part 820 regulation. -Experienced (3-5 years) in the development and execution of validation documentation and protocols, including Validation Assessments, Validation Plans, -Requirements Specifications (URS, FRS), IQ, OQ, PQ and Reports.? -Experience developing and implementing Measurement System Analysis (MSA), including Attribute Analysis, GR&R, DOEs.? -Project management skills required. -Fully bilingual (English and Spanish). -Experience in Minitab (software statistical tool). -Good technical writing skills. ? Con Alguna Experiencia Requires Intermediate Experience
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