I am a qualified ISO 13485: 2016 lead auditor, quality manager and a certified member of the six sigma green belt. My previous working experiences in medical device industry were management representative, medical QA/QC, after sales service management and had received the training of clinical research associate. I majored in Biomedicine and studied medical laboratory management, conducted experiments in molecular biotechnology and statistical analysis. In my working history, I started from the QC specialist about genomic DNA extraction reagents and instruments. And then, I became the QA specialist maintaining laboratory equipment and review the quality SIP and SOP to make sure all the inspection process and instruction are fulfilled the specification and ISO 13485 requirements. Then, I was promoted to the QA/QC manager and management representative to monitor the whole quality system and in charge of applying CE mark, ISO 13485 and trained for customers in Asia and European countries. Finally, I am in charge of manager in global Quality System Department. My job objectives are leading the team to established and monitored the whole quality and service system, solve the global customers' complaints, do the product external training and audit suppliers, customers all over the world, carry out post-market surveillance to analysis and improve the service quality and implement the customer satisfactory activities. In addition, I have lot of business trip experience all over the world (such as Italy, Thailand, Switzerland, Chian……and so on) and current one was in 2023, helped Italian customer reworking products. I am excellent at setting up systems and troubleshooting, and I have strong problem-solving and analytical skills. Furthermore, I enjoy challenges and possess great English communication skills. 我是合格的醫療器材品質管理系統ISO 13485:2016主導稽核員、品質經理和六標準差綠帶訓練合格人員。我之前在醫療器材產業的工作經驗是品質經理、管理代表、醫療品保/品管、售後服務管理，並接受過臨床研究員的訓練。碩士班研修生物醫學，學習實驗室管理、執行生化實驗及統計分析。 在我的工作經驗中，我是從基因組合核酸萃取試劑和儀器的品管專員開始的。然後，我成為品保專員，維護實驗室設備並審查品質 SIP 和 SOP，以確保所有檢查流程和指令均符合規格和 ISO 13485 要求。隨後，我晉升為 品保/品管經理和管理代表，負責監控整個品質體系，負責申請 CE 標誌、ISO 13485，並為亞洲和歐洲國家的客戶提供培訓及客訴處理。 最後，我在 Wellell Inc.（也稱為 Apex Medical Corp.）擔任全球品質系統部門經理。我的工作目標是帶領團隊建立並監控整個品質和服務體系，解決全球客戶的投訴，對世界各地的供應商、客戶進行產品外部培訓和審核，進行上市後監督以分析和改進服務質量，實施顧客滿意活動。另外，我有很多世界各地出差的經驗（例如義大利、泰國、瑞士、中國…等等），目前一次是在2023年，前往義大利幫助客戶重新定義及重工產品。 我非常擅長設定係統和故障排除，並且具有很強的解決問題和分析能力。此外，我喜歡挑戰並擁有良好的英語溝通能力。