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Korea Korea, South

Director of QMS

(2012~ recently) : Quality Management System Director - Medical Device Quality Management Dept. Officer - ISO 13485 QMS Administration and Internal Auditor - MDD CE ( 93/42/EEC) Technical documentation and certification Affairs ( Usability engineering process / Risk management /CER / SW Validation/ etc. ) - FDA 510k certification Affairs - Medical device development process innovation (2011~2012): Ufirst Business Consulting Corporation - SME Quality Management Systems Consulting - Six Sigma training and application - Statistical Quality Control - Business Strategic Planning - Improve SME skills training consulting (2009~2011) : Chungbuk solar industry association. - Promotion C...