SCOPE OF THE ROLE AND BASIC PURPOSE/职位范围与基本目的 ▪ Perform various test on test pieces in the Material Lab in Suzhou, China. (在苏州材料实验室对样品 进行各种测试) ▪ Maintain the Material Lab and system (对材料实验室和系统进行维护) KEY RESPONSIBILITIES/TASKS (indicate estimated % of time spent where possible)/ 主要职责/ 任务(以时间的百分比表示) 1. 60% - Quality (质量) 2. 10% - Procurement, supplier (采购,供应) 3. 30% - Manufacturing, facility (制造,设备) ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标 ▪ Perform the principal duties of the Material Test Technician position: (完成材料测试员的主要职 责) o Perform required various test on the test pieces per requirements in Johnson & Johnson (Medical) Suzhou Co. Ltd. (在强生苏州医疗器材有限公司完成对样品的各种测试要求) o Manage test pieces and documents as required. (按照要求管理并记录测试样品) o Maintain the Material Lab and the equipment/instrument used in good working condition. (维护材料实验室并始终保持设备在最佳的工作条件) o Compile non-conformance data. (整理不符合项的数据) o Attend test method validation (GR&R, etc.) (参加测试方法的验证,例如重复性和再现性) o Support Calibration Technician for the work. (支持校准技术员的工作) o In partnership with manufacturing department. (与生产制造技术部门进行合作) ▪ In accordance with DePuy Worldwide Quality strategy, participate to the development of the quality system and its day to day implementation: (和DePuy 全球战略保持一致,参与质量体系的发展以及日常的实施) o Participate in training or workshop employees and deploy on site the Quality philosophy based on FDA QSRs, ISO 9000 and CFDA requirements. (参与培训,深入车间并且按照FDA QSRs, ISO9000 以及 CFDA 的要求对现场进行规划和部署) o Ensures compliance to all GMPs and MDD requirements. (确保遵守所有的生产质量管理规范和欧盟医疗器械的要求) ▪ Perform all job duties in full accordance with: (按照以下要求完成任务)
o The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information. (强生有关信息,资产保护,密码维护,保密,关键商务信息保护的政策) o All J&J policies and local regulations. (遵守强生的政策和地方法规) o The policies of the Health Care and Environmental programs. (医疗保健以及环境规划的政策) o The code of conducts policies. (行为守则政策) ▪ Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…). (审计公司在职员工在质量,健康和安全以及环境等方面的全部责任和义务) ▪ Complete other tasks assigned by supervisor. (完成主管交代的其他任务) ▪ Additional requirement for Senior Material Technician: (高级材料技术员的其他要求) ▪ Related equipment and test method qualification (相关设备和测试方法的验证) ▪ Maintain related procedure for various test (维护各种测试的相关程序) ▪ Connect with WW virtual team to implement new requirement and problem solving. (和全球虚拟团队保持联系并实施新的要求和解决问题)