Summary 职责综述：
In accordance with the company’s Quality Management System and manufacturing process requirements, perform the assembly, inspection, and related documentation of active medical devices, ensuring that products comply with quality standards and regulatory requirements.
按照公司质量管理体系及生产工艺要求，完成有源医疗器械产品的组装、检测及相关记录工作，确保产品符合质量标准及法规要求。
Essential Duties and Responsibilities 基本职责：
1. Perform the assembly and testing of active medical devices in accordance with Work Instructions (WI), Standard Operating Procedures (SOP), and process documentation. 根据作业指导书（WI）、标准操作规程（SOP）及工艺文件，执行有源医疗器械的组装和测试作业。
2. Be responsible for the assembly and interconnection of electronic components, wiring harnesses, modules, and complete devices. 负责电子组件、线束、模块及整机的组装与连接工作。
3. Perform in-process inspections and basic functional testing as required to ensure product quality meets specifications. 按要求开展过程检验及基础功能测试，确保产品质量符合规范。
4. Accurately and promptly complete production and quality records, ensuring data is true, complete, and traceable. 正确、及时填写生产记录及质量记录，确保数据真实、完整、可追溯。
5. Comply with GMP and the company’s Quality Management System requirements to ensure operations are in accordance with established procedures. 遵守GMP及公司质量管理体系要求，确保操作符合规范。
6. Promptly report any quality or production abnormalities and support root cause analysis and corrective actions. 发现质量异常或生产异常时，及时上报并配合问题分析与改进。
7. Assist in pilot production, validation, and process improvement activities. 配合进行试产、验证及工艺改进工作。
8. Be responsible for 5S management of the work area, maintaining a clean and orderly environment. 负责作业区域5S管理，保持现场整洁有序。
9. Complete other tasks assigned by supervisors. 完成上级安排的其他相关工作。
Job Qualifications 职位所需资格：
1. Demonstrate a basic knowledge of China medical device GMP and ISO 13485 requirements. 对中国医疗器械GMP、ISO 13485等有一定了解。
2. Good English reading and writing skills. 良好的英语读写能力。
3. Shows a high level of diligence and initiative, with strong patience. 工作认***动，有耐心。
4. Offer good cooperation and communication for whole team, good interpersonal skills. 为整个团队提供良好的合作与交流，有良好的人际关系。
5. Familiar with Excel, Word and Netware. 熟悉Excel、 Word和网络操作。
Education and/or Experience 教育和经验：
1. College degree or above (science and engineering majors preferred). 大专及以上学历（理工类专业优先）。
2. At least 2 years of experience in active medical device assembly or precision assembly is preferred. 具备2年及以上有源医疗器械或精密装配组装经验者优先。
3. Working experience in an ISO 13485 or GMP environment. 有ISO 13485或GMP体系环境工作经验。
4. Familiarity with basic ESD protection requirements is preferred. 熟悉ESD防护基本要求者优先
5. Preferably with basic electrical knowledge; candidates holding a valid electrician certificate will be given priority. 具有电工相关知识，有电工证者优先。
6. Willing to work Ｏn shifts. 愿意轮班工作。
