- Experienced in manufacturing processes and solving production problems , medical validation & verification activities , testing and part approval processes , technical documentation compliance to ISO 13485 & 21 CFR 820 standards. Strong skilled in Medical Devices, test designs , change managements , risk managements- Performing packaging process validations and also packaging design change validations according to ISO 11607-1&ISO-11607-2.- Performing process validations(Installation qualification, software validations, operational qualification, performance qualification) acc. to ISO-EN-ASTM medical device standards working parallel to R&D.-Performing part verifications acc. to ISO-EN-ASTM medical device standards working parallel to R&D.-Analysis and solutions of production problems, bottlenecks, backlogs etc.; creation and implementation of improvement projects with an 6-sigma&Lean approach- Sustainability of production acc. to GMP and FDA regulations- Monitoring the production processes-Evaluation of customer complaints, investigating the root causes for non-conformities took place in the manufacturing and to find the solution for the problems associated with them-Creation of testing & part approval procedures within Getinge CP Antalya.-Creating good documentation such as basic operation procedures, standard instructions, test plan & test reports and support documents to improve the production quality and provide sustainable production.- Creating test plan and test reports for packaging performance tests according ASTM D4169.- Creating test plan and test reports for packaging stability tests.(Aging)- Good knowledge of sterile barrier tests.- Responsible for the thermoforming machine, router cutting machine process- Material qualification creation.