Thế Đỗ Văn

07/2018 - Now: Process Engineer | Terumo Vietnam Management the project: Prepare plan and schedule, risk analysis, risk management (based on FMEA), monitor progress, report, discussion, contact to related divisions Conduct Internal audit to maintenance of the quality management system. Prepare validation document, respond to the ISO auditor, TUV auditor. Dealing with international regulations (ISO 13485, ISO 14971, MDD, MDR…) Go to supplier to evaluate the supplier about new machine, new raw material Transfer new products or processes, train newcomers. Research and implement improvements to reduce cost, increase capacity as well as innovate product quality Investigate and handle abnormalities. Co-ordinate Complaint Handling and Change Control with relevant departments, initiation of CAPA and follow-up on implementation. Provide training to relevant persons on process controls documentation. 09/2017 - 07/2018: Trainee | Ashitaka factory – Japan Take part in engineering training course in Japan: polymers in medication, extrusion engineering, IH welding... Learn about new product items in order to transfer to Vietnam. Logical thinking, presentation by PREP method, 7 QC tool, ... 05/2015 - 09/2017: Production Engineer | Terumo Vietnam Support production, monitor and evaluate the status and operability of production equipment. Solve problems, ensure production progress and product quality. Make technical reports as a basis for changes in manufacturing procedures or product standards. Validate new machines, set operating conditions for machines Perform tests and analyze data to evaluate product quality