1.規劃和籌建廠房和產線
2.工廠營運管理
3.撰寫營運計劃書
4.申請進駐科學園區
5.初期會先在內湖上班

1. Plan, implement and coordinate activities related to quality system, quality assurance, quality verification, customer problem handling and daily management of the department.
2. Collection and update of domestic/foreign medical device regulatory certifications and related regulations and standards.
3. ISO13485 and GMP quality system audit related matters.
4. Matters related to domestic/foreign medical device clinical trials.

1. Quality control: Advanced review work of the NPI process, supervising the compliance of suppliers, assessing quality risks in product development and mass production introduction; assisting department heads in reviewing various quality-related agreements
2. Supplier management: Lead the recognition, assessment and regular review and coaching of suppliers by various departments; review the evaluation data of new materials, new suppliers and foundries; lead the communication of the company's various engineering change needs to the foundries , and track and confirm the evidence and information provided by the foundry to assess risks
3. Environmental protection control: supervise the various OEM processes and product environmental compliance of the foundry, supervise the procurement department to communicate the requirements for environmental management substances (environmentally banned substances) to external suppliers, and confirm the evidence and information provided by extern

*負責Apple專案
*帶領下屬PM完成公司指派專案任務

1.公司營運政策的計畫推行與品保部展開工作及年度預算規劃
2.領導品保部相關工作執行與KPI的達成工作
3.管理與監督品質體系運作與執行工作
4.主導客戶稽核相關事務工作
5.參與跨部門溝通會議與督導相關事務執行