Working for both Manufacturing and Quality Operations activities to support Validation on new equipment & equipment relocation.Validation activities for product transfer projects , New product introduction.EU-MDR projects New product introduction (NPI) for manufacturingDesign changesManufacturing changesdevelopment of new proceduresProcedure releaseCSV-ETest Method validationprocess data analysis through Minitab statistical tool.Risk ManagementPLM and ERP changes implementationcoordinating with other department including but not limited to Quality Engineering, Product development, Regulatory Affairs to close the activities. NC, CAPA activities

Manufacturing EngineerSupported Locations: Brandywine (West Chester), Palm beach gardens (Florida), Monument (Colorado), Cork (Ireland).Activities: Validation of new equipment, New product introduction in manufacturing, Manufacturing changes.

Medical Devices Quality Engineer Client: Cook Medical (Bloomington) for DHF remediation activity.Client: DePuy Synthes for Trauma CMF & joints domain on tech files & manufacturing activities.

Quality Engineerworking for Client (DePuy Synthes) at onsite location.

QUALITY ENGINEER & REGULATORY AFFAIRS ASSISTANTPreparation of compliance certifications related to RoHS, REACH, Conflict minerals, BSE/TSE, BPA declaration.PFMEAData analysis through MINITAB statistical software.prepare overall summary report to conclude the results of data analysis.Inspect & release parts during the manufacturing of products.

Shift EngineerCoordinating with Production, planning and control team (PPC) for daily production activities. GEMBA study Maintaining 5Spreparation of PPAP & APQP documents. support Audit activities.