生物相容性专家-06604

This position is responsible for test request review and projectexecution of medical device biocompatibility testing with
In-house laboratory, and also support sales on medical devicebiocompatibility testing business development.
该岗位负责医疗器械实验室生物相容性有关测试项目评估和开展实施工作，同时支持销售人员生物相容性测试业务的开发。
岗位职责
1. Biocompatibility test request review with associated test planpreparation; 10%
生物相容性测试项目要求评估及测试计划准备
2. Follow test plan and product specification to perform test in labwithin required timeline ; 30%
遵循测试大纲计划和产品技术规格书在要求的周期内完成项目的测试
3. Test data and record check to ensure accuracy and traceability; 10%
测试数据和记录检查确保准确性和可追溯性
4. Active communication with timely update on test status to customerservice; 10%
同客服人员积极沟通确保测试进展状态的适时更新
5. Test sample management and final test report preparation.10%
测试样品的管理和最终测试报告的准备
6. Maintain good performance of test device, equipment and facility 10%
维护测试设备和实验室设施的良好状态。
7. Ensure test activities to comply with ISO 17025, GLP and internalquality requirements. 10%
确保测试活动符合ISO 17025/GLP/和内部质量管理体系要求
8. Participate in new test method developing and lab test capabilityextension 5%
参与新测试方法开发以及新测试能力的拓展
9. Other lab accreditation or on-site audit related work as assigned. 5%
其他实验室认可及现场审核有关的工作安排
任职条件
1. Bachelor’s degree or above, major in biology /microbiology/biochemistry or equivalent
本科以上学历，生物学/微生物学/生物化学或相关专业
2. Knowledge of relevant international standards especially ISO 18562series or ISO 10993 series;
对测试相关标准如ISO 18562和ISO 10993等国际标准有一定了解
3. Knowledge of lab ISO17025 and OECD GLP principles is a plus;
熟悉ISO 17025和GLP实验室体系要求的优先
4. 5 years working experiences of biocompatibility testing laboratory ofMedical device；
5年左右医疗器械产品生物相容性测试经验
5. Good communication skill;
良好的沟通技巧
6. Good understanding and fulfillment to working related targets,standards, policies, procedures and instructions;
了解测试行业有关政策规范,流程和工作要求
7. Respect and safeguard company's image, reputation and benefit;
尊重和维护公司的形象信誉和利益
8. Diligence, self-motivation, self-improvement and strong teamwork spirit;
勤奋上进心团队合作精神;
9. Good computer skill; Good command of English can be better.
良好的计算机技能;英语熟练