主要职责 Main Responsibilities: 1. Quality management system implementation and maintenance 质量管理体系的实施与维护: 1. Collect laws and regulations related to medical devices （ Including but not limited to NMPA, MDR ）, analyze applicability, and implement them within the company.收集医疗器械相关法律法规（包括但不限于NMPA、MDR），分析其适用性，并在公司内部实施。 2. Organize the internal audit related to the maintenance of quality management system, docking with the notified body and the external audit of the NMPA, and organize management review, follow up the audit of non-conformance until it is closed.组织与质量管理体系维护相关的内部审核，对接公告机构和国家药监局的外部审核，并组织管理评审，对不符合项进行跟踪审核，直至审核结束。 3. Understand the establishment, implementation and maintenance of PMS procedures related to MDR, maintain company and product information in NMPA and EU databases.了解与MDR相关的PMS程序的建立、实施和维护，在NMPA和EU数据库中维护公司和产品信息 2. product certification产品认证: 1. Familiar with the declared products, technical requirements, instructions, labeling machine packaging and other information, promote the registration progress.熟悉申报产品、技术要求、说明书、贴标机包装等信息，推动注册进度 2. Maintain effective communication with relevant departments and outsourcing agencies, and assist engineering department to complete the work of docking inspection agencies, inspection and testing.与相关部门及外包机构保持有效沟通，协助工程部完成对接检验机构、检验测试工作 3. Responsible for product registration and submission, including registration information preparation, sorting, review, issue and repair, and maintain product registration information.负责产品注册和提交，包括注册信息的准备、整理、审核、发布和修复，并维护产品注册信息 4. Understand the application process for overseas medical qualifications (MDA, MDR, etc.)了解海外医疗资格（MDA， MDR等）的申请流程
3.Management system requirements管理体系要求： 1. Take the safety responsibilities of the position in accordance with related laws and regulations, please refer to the "Safety Production Responsibility System" of the position for details.根据相关法律法规承担本岗位的安全责任，详见本岗位《安全生产责任制》。 2. Have the basic knowledge and awareness related to the ISO9001/14001/45001/50001 system standards and other product certification that corresponding to the job skill requirements. Please Refer to the department's personnel competency matrix for details.具备ISO9001/14001/45001/50001体系标准及其他与岗位技能要求相对应的产品认证的基本知识和意识。详情请参阅本署的人员胜任能力表。
Competence and qualification能力与资格： Experience requirements经验要求 : 1. 3 or more years’ experience in 13485 QMS and product certification, preferably in product certification.3年以上13485质量管理体系和产品认证经验，有产品认证经验者优先 2. Good knowledge of the medical application requirements industry.良好的医疗应用行业知识。
Educational requirements学历要求 : 1. University degree or above, majored in mechanical engineer、biomedical science or equivalent. 大学本科及以上学历，机械工程、生物医学或相关专业。
Personality requirements个性要求 : 1. Fluency in Chinese with a good command of English is a requirement.要求汉语流利，英语熟练。 2. Strong interpersonal communication and leadership skills.良好的人际沟通和领导能力 3. Self-starter做事主动的人 4. Good commercial understanding and skills.良好的商业理解和技能。 5. Travelling within the region is required.需要在区域内出差。
Competency and personality requirements能力及个性要求: 1. Collect and analyze information收集和分析信息 2. Result orientation结果取向 3. Understanding and meeting customer expectations理解并满足客户的期望 4. Adapting and responding to change适应和应对变化 5. Continuous improvement持续改进
