岗位职责:
1体系建立与维护
System establishment and maintenance
组织建立和健全公司ISO13485、ISO9001、医疗器械生产质量管理规范、经营质量管理规范等管理体系，确保有效运行
Organize the establishment and improvement of the company’s management systems such as ISO13485, ISO9001, medical device production quality management specifications, and operational quality management specifications to ensure effective operation
组织修订、完善质量管理体系文件；
Organize the revision and improvement of quality management system documents;
推动和优化工作质量体系，确保流程满足各国质量法规监管要求，推动流程效率不断提升。
Promote and optimize the work quality system, ensure that the process meets the regulatory requirements of various countries
quality regulations, and promote the continuous improvement of process efficiency.
2指导和监督体系运作
Guidance and supervision system operation
依据质量体系文件要求，进行质量体系策划，并监控策划实施情况；
Carry out quality system planning according to the requirements of quality system documents, and monitor the implementation of the planning;
组织编制质量管理体系内审和管理评审实施计划，并主导完成内审和管理评审，输出内审、管理评审报告；
Organize the preparation of the implementation plan for the internal audit and management review of the quality management system, and lead the completion of the internal audit and management review, and output the internal audit and management review reports;
根据第二、三方审核计划，策划审核准备及审核安排，指导各部门对审核发现的不符合项整改及效果验证，收集和汇总不符合项整改资料；
According to the second and third party audit plans, plan audit preparation and audit arrangements, guide various departments to rectify and verify the non-conformities found in the audit, collect and summarize non-conformance rectification data;
参与各部门质量提升及提案改善项目、改善效果评审。
Participate in the quality improvement and proposal improvement projects of various departments, and the improvement effect review.
3纠正预防措施推进
Corrective and preventive measures advance
及时收集、统计、分析体系管理相关数据结果，并负责验证各项纠正、预防措施及改进方案的有效性；
Collect, count and analyze system management related data results in time, and be responsible for verifying the effectiveness of various corrective and preventive measures and improvement plans;
负责质量问题的跟踪处理。
Responsible for the tracking and handling of the quality issues.
4体系培训
System training
负责公司员工管理体系知识的培训；
Responsible for the training of company employee management system knowledge;
组织质量体系文件培训，并指导各部门建立和完善质量管理体系。
Organize quality system document training, and guide various departments to establish and improve the quality management system.
5体系档案管理
System file management
体系管理相关文件、记录的存档管理。
Archive management of relevant documents and records of system management.
任职要求:
专业资格/职业资格
Professional qualifications
具备相关的专业知识背景
Have relevant professional knowledge background
工作经验
Work Experience
3年以上医疗器械行业相关经验
More than 3 years of relevant experience in the medical device industry
知识技能
Knowledge skills
熟悉或了解质量体系标准要求：ISO13485、FDA CFR820、医疗器械生产质量管理规范等，内审员优先；
Familiar with or understand the quality system standard requirements: ISO13485, FDA CFR820, medical device production quality management specifications, etc., internal auditors are preferred;
掌握数据分析的方法和工具，掌握质量管理常用的工具和方法；具有处理质量问题的良好的思路和逻辑，以及跨部门沟通和协调的能力；
Master the methods and tools of data analysis, master the tools and methods commonly used in quality management; have good ideas and logic for handling quality issues, and the ability to communicate and coordinate across departments;
熟练使用办公软件；
Proficiency in using office software;
英语沟通流利者可优先考虑
Fluent English communication is preferred
能力素质
Competence
具备高度责任心，工作态度严谨、细致；
Have a high sense of responsibility, rigorous and meticulous working attitude;
思维清晰有条理，良好的表达能力，能够合理安排时间独立完成工作；能承受较大工作压力。
Clear and organized thinking, good expression skills, able to arrange time to complete work independently; able to withstand greater work pressure.