Duties and Responsibilities in this job: 主要工作职责: 61 Conduct inspections and testing of incoming raw materials and components as required. 负责原材料和部件的来料检查和检验工作。 61 Perform in-process and final inspections, including Device History Record (DHR) filing . 负责过程检验、产品检验工作以及器械历史记录(批记录)的归档工作。 61 Provide quality support regarding products, processes, and systems. 提供产品,过程及质量体系的支持工作。 61 Oversee the inspection system, Ensure Calibration log ,equipment and fixture and tools in well status 全面监督检验系统,确保校准台账,设备和工装夹具等在良好状态。 61 Implement the quality system to the highest standards. 负责质量管理体系的执行以达到更高的水准。 61 Promote Good Manufacturing and document Practices and ensure compliance with quality system requirements. 执行良好生产生产规范及文件规范以确保符合质量管理体系要求。 61 Support Customer Complaints, Corrective and Preventive Actions (CAPA), and non-conforming product/process and adverse event issues . 支持客户投诉,CAPA和不合格产品、过程及不良事件等调查工作。 61 Participate in process development and transfer projects. 全面参与过程开发及产品转移项目。 61 Collecting the quality data and Support weekly and monthly quality meetings. 收集质量数据并支持周会及月度会议。
Our ideal candidate will have the following qualifications and skills: 任职资格: 61 Minimum of three years of related work experience or a combination of experience. 三年以上工作并具备相关工作经验。 61 College degree or above, Major in electronics or communication is preferred 大专或以上学历要求,电子或通讯等相关专业为佳 61 Demonstrated excellent organizational skills and initiative. 具备优秀的组织能力和主动性。 61 Strong written and verbal communication skills are essential. 良好的书面和口头沟通能力。 61 Proficient in Microsoft Word, Excel, and PowerPoint. 熟悉Microsoft工作软件。 61 Ability to work under pressure, manage time effectively, and prioritize tasks to meet deadlines. 能够在压力下工作,有效地管理时间,并优先安排任务以满足最后交付。 61 Experience in applying product inspection techniques and strong root cause analysis and problem-solving skills is an advantage. 有产品检验技术应用经验,具有较强的根本原因分析和解决问题的能力优先考虑。 61 Familiarity with the medical device industry and understanding of regulatory compliance (GMPISO 13485) is desirable. 熟悉医疗器械行业,了解法规GMP,ISO13485为佳。