Must possess a min. of 1 year of experience with each of the followingbr br FDA 21 CFR Part 820, ISO 13485, ISO 14971, ISO 9001 and GMPbr Executing Lean transformation projects, product transfers, cost savings and material replacement projects using project mgmt. methodologiesbr Process characterizations, optimization DOE, Time studies,br Identifying root cause of product or process nonconformances using Six Sigma Methodologiesbr Establishing process flows, conducting IQOQPQbr DRM and VAVEbr Statistical analysis using Gage R R, ANOVA, variables data distribution, sample size calculation, statistical process control, hypothesis testing and Normality Assessmentsbr br This position is open to telecommuting from anywhere in the United States.

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