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·Write Validation Master Plans; develop and conduct protocols for validating new equipment and processes.
·Perform/facilitate DFMEA, PFMEA, and risk assessments; tracks follow up actions.
·Operate inspection procedures and develop a team approach to addressing product quality issues.
·Perform batch record review to develop quality metric and drive defect reduction effort.
·Perform statistical analysis of process data; interpret, compile and organize results.
·Perform periodic audits of the quality system.