Manage validations, devices, and molding quality related activities in the plant. I have also managed calibrations, critical systems, and steam sterilization quality related activities in the plant. Direct team of quality engineers and quality associates in validations of equipment and software (computer control systems, PLC)Work with employees across the plant to assist in decisions for software modifications and equipment adjustmentsCoordinate sterilization requalifications and review all qualification packagesEnsure all procedures for validations and risk management conform to corporate specification requirementsEnsure devices and molding manufacturing departments meet quality requirements for release, NCRs/CAPAs, complaints, monthly capability analysis, process improvements, etc. Train plant employees on validation requirementsDirected the plant calibration teamCoordinated with plant critical systems team and facility engineers on changes to the plant and meeting regulatory requirementsQuality System Representative for software applications across the plant and plant data integrity leadSubject Matter Expert for risk management and validation proceduresEnsure procedures meet current regulatory requirements and participate in plant auditsManage multiple projects as well as completing management responsibilities Leadership, mentoring, and management; technical writing

Responsibilities Included:Set up quality system and documents according to ISO 13485Oversee ISO certification which was achieved within 2 months of hireRun lab testing on raw materials X-ray Diffraction Analysis Metallographic Analysis using vision softwareManage calibration requirements and perform calibrations on small measuring instruments Direct Management ReviewsInvestigate production non-conformities and oversee resolutionsEstablish training requirements and manage training records Complete internal auditsQuality tracking of productionCommunicate with customers and suppliersUse customized SAP program for productionEnsure company meets all regulatory requirementsTraining completed at Surface Dynamics:Calibration Training through the University of TennesseeInternal Auditor TrainingXRD Training through Rigaku

Responsibilities include: Write and perform validations on new equipment (equipment and software validations) - Including Risk Management and product testing. Validate automation equipment and molding equipment Manage validation project time linesGage R & R projectsCommunicate with employees across Baxter corporationPrepare presentations for upper management meetingsAnalyze data gathered from validations using Excel (mean, average, Cpk, etc.)Write/Maintain programs in SPC for tracking manufacturing data and release of productInvolved in small groups for manufacturing process improvements Team leader of the validation improvement process team (implement validation improvements). Required to track updates of team, lead meetings and keep up with meeting minutes, and update management on progress.Training completed at Baxter Healthcare:Lean White Belt Training (2007)Allen Bradley SLC 500 Maintenance/Troubleshooting (2008)RJG Mold Masters I Training (2009)Project Management Training (by a PMI certified trainer) (2010)