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I. Position Summary
This position is responsible for medical device microbial testing in NAM lab.
该岗位负责无源医疗器械实验室产品微生物相关的测试工作。
II. Responsibility and Authority
1.Carry out daily microorganism testing including sterility test and bioburden etc under specified working plan; 45%
按工作计划进行无源医疗器械微生物相关测试包括无菌检测和生物负载等项目。
2. Follow standards and lab WI to carry out microorganism testing implementation and test data verification 20%
遵循测试标准和实验室作业指导书开展微生物检测以及测试数据整理验证等工作
3. Help to check/ maintain good performance of equipment and facility. 10%
负责实验室测试设备和操作区域的整理维护。
4. Participate in testing method or test protocol development of medical devices in lab. 15%
参与医疗器械实验室测试方法和检测方案的开发工作。
5. Support lab internal or external audit work and also other duties assigned by Leader 10%
支持实验室内外审工作以及主管安排的其他任务事项。
III. Education and Experience
1. Bachelor degree or above, major in microorganism, bioscience or related major.;
本科以上学位,微生物,生物科学或相关专业
2. Have a certain understanding of microorganism testing on non-active medical devices.
对无源医疗器械微生物测试有一定了解
3. Knowledge of ISO17025 or GLP quality management is a plus;
具备实验室ISO 17025或GLP体系经验优先
4. Good understanding and fulfillment to working related targets, policies, procedures and instructions;
了解实验室测试有关的工作目标流程/政策要求等。
5. Respect and safeguard company’s image, reputation and benefit;
遵守公司制度并积极维护公司利益。
6. Diligence, self-motivation, self-improvement and strong teamwork spirit;
自我激励并具备团队精神
7. Good computer skill;
良好的计算机操作能力
8. Good command of English is a plus;
英语熟练者优先