Perform the principal duties of the Material Test Technician position: (完成材料測試員的主要職責)
o Perform required various test on the test pieces per requirements in (Medical)
Suzhou Co. Ltd. (在蘇州醫療器材有限公司完成對樣品的各種測試要求)
o Manage test pieces and documents as required. (按照要求管理并記錄測試樣品)
o Maintain the Material Lab and the equipment/instrument used in good working condition. (維護材料實驗室并始終保持設備在最佳的工作條件)
o Compile non-conformance data. (整理不符合項的數據)
o Attend test method validation (GR&R, etc.) (參加測試方法的驗證,例如重復性和再現性)
o Support Calibration Technician for the work. (支持校準技術員的工作)
o In partnership with manufacturing department. (與生產制造技術部門進行合作)
? In accordance with DePuy Worldwide Quality strategy, participate to the development of the quality system and its day to day implementation: (和 DePuy 全球戰略保持一致,參與質量體系的發展以
及日常的實施)
o Participate in training or workshop employees and deploy on site the Quality philosophy based on
FDA QSRs, ISO 9000 and CFDA requirements. (參與培訓,深入車間并且按照 FDA QSRs, ISO 9000 以及 CFDA 的要求對現場進行規劃和部署)
o Ensures compliance to all GMPs and MDD requirements. (確保遵守所有的生產質量管理規范和歐盟醫療器械的要求)
? Perform all job duties in full accordance with: (按照以下要求完成任務)
o The policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information. (有關信息,資產保護,密碼維護,保密,關鍵商務信息保護的政
策)
o All policies and local regulations. (遵守政策和地方法規)
o The policies of the Health Care and Environmental programs. (醫療保健以及環境規劃的政策)
o The code of conducts policies. (行為守則政策)
? Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…). (審計公司在職員工在質量,健康和安全以及環境等方面的全部責任和義務)
? Complete other tasks assigned by supervisor. (完成主管交代的其他任務)
? Additional requirement for Senior Material Technician: (高級材料技術員的其他要求)
? Related equipment and test method qualification (相關設備和測試方法的驗證)
? Maintain related procedure for various test (維護各種測試的相關程序)
? Connect with WW virtual team to implement new requirement and problem solving. (和全球虛擬團隊保持聯系并實施新的要求和解決問題)