36 months in the following Lean Manufacturing and Six sigma Principles applicable to continuous process improvement; 21 CFR Part 820 and ISO 13485 Quality System Regulations applicable to medical device manufacturing; cGMP current good manufacturing practices; Product development and transfer from development to sustaining; Labeling standards and compliance to regulations; Risk Management tools such as Process FMEA Failure Mode Effect Analysis and quality tools such as Fishbone diagram, 5Ys etc; and Quality Management systems applicable in the medical device manufacturing including IUO, RUO and IVD products. Parttime telecommuting allowed.
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