熟悉生產單位管理或熟悉生管作業流程管理

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

負責海外營運單位生產製造或製程工程單位管理