Quality Engineer

Job Description:Review new and modified processes.Analysis for validation or revalidation requirements (IQ/OQ/PQ).Validation protocols creation.Validations tracking.Support on validation corrective actions required.Report validation results.Statistical support on production processes:Required SPC tool evaluation.Report validation results.Capability studies implementation.Gage R&R implementation.Support to implement methods/altern sampling.Support to eliminate destructive tests.Support to improvement projects.Job Requirements:Experience:Industrial Engineer, Mechanical Engineer, Electronics Engineer, or similar.Medical Industry Experienced.QMS and ISO Standard Knowledge (ISO13485 and/or FDA GMP)Manufacturing Process 3-year-experienced.New Product development/Process transfers/Process improvement experienced.English about 85% Preferred (spoken, written, read).Operating Company: Spark#J-18808-Ljbffr