【岗位看重点】
1. 二类及以上外科医疗器械5年经验（偏外资经验）
2. 带领团队1-2战略升级，ISO13485质量管理体系经验+良率提升底层逻辑设计及推动
【岗位总述】
确保企业质量管理体系有效运行，保障产品全生命周期符合法规、标准及客户要求，通过持续改进提升产品质量和企业合规能力，最终实现对患者安全的保障和市场竞争力的增强。
To ensure the effective operation of the enterprise's quality management system, guarantee that the entire product life cycle complies with regulations, standards, and customer requirements. Improve product quality and the enterprise's compliance capabilities through continuous improvement, and ultimately achieve the protection of patient safety and the enhancement of market competitiveness.
【岗位职责】
1. 负责质量部管理体系的建立，运行，维护，组织内部审核完成内审报告及相关记录，并监督检查改进和落实情况；
Responsible for establishing, operating, and maintaining the quality department's management system; organizing internal audits, completing internal audit reports, and related records; and supervising the implementation of corrective actions and follow-up.
2. 负责组织质量工程师对供应商审核及评审设计开发各阶段相关文件，监督设计开发过程符合性；
Responsible for organizing quality engineers to conduct supplier audits and review design and development documents at various stages, ensuring compliance with design and development processes.
3. 负责医疗器械产品质量管理，依据质量控制程序要求，正确识别各项质量管控点，组织制定管理规程，指导、监督执行；
Responsible for quality management of medical devices, identifying key quality control points based on quality control procedures, developing management regulations, and guiding and supervising their implementation.
4. 负责组织专人收集与医疗器械生产、经营相关的国内外法规标准等有关规定、实施动态管理；
Responsible for organizing the collection of domestic and international regulations and standards related to medical device production and distribution, and managing their implementation dynamically.
5. 加强生产过程中的质量控制，组织质量工程师对质量管理中出现的质量问题进行分析、判断和处理，组织实施不合格品处理，执行标识、记录、隔离、临时措施和/或纠正预防措施、关闭；
Strengthen quality control during production processes, organize quality engineers to analyze, judge, and handle quality issues, implement nonconforming product management (including identification, record-keeping, isolation, temporary measures, and corrective/preventive actions), and ensure closure of issues.
6. 负责组织对生产批记录的审核及成品放行；
Responsible for organizing the review of production batch records and release of finished products.
7. 组织编制、审核质量管理体系相关的程序文件、管理制度及SOP等，确保质量管理工作的规范化和标准化，如依据《医疗器械监督管理条例》、《医疗器械生产质量管理规范》、ISO13485及国外相关体系法规等制定完善的质量管理体系文件，并监督各部门严格执行；配合技术部涉及的验证工作，组织专人校准相关设施设备量具及仪表等；
Organize the development and review of quality management system-related procedures, management systems, and SOPs to ensure standardized and regulated quality management. This includes establishing a comprehensive quality management system in accordance with regulations such as the "Regulations on the Supervision and Administration of Medical Devices," "Good Manufacturing Practices for Medical Device Production," ISO 13485, and other relevant international standards. Supervise strict implementation by all departments and support validation activities related to the technical department, including calibration of facilities, equipment, gauges, and instruments.
8. 组织质量工程师及时收集、分析和处理客户投诉，组织相关部门进行原因分析，制定并实施纠正预防措施，防止问题再次发生；
Organize quality engineers to collect, analyze, and handle customer complaints, conduct root cause analysis with relevant departments, and implement corrective and preventive actions to prevent recurrence.
9. 根据公司的发展战略和市场需求，组织制定质量目标和质量计划，并将其分解到各个部门和岗位，确保质量目标的有效落实和达成；
Based on the company's development strategy and market demands, formulate quality objectives and plans, break them down to various departments and positions, and ensure their effective implementation and achievement.
10. 参与新产品研发项目的质量策划，从质量角度对产品设计、工艺选择、原材料采购等环节提出专业意见和建议，确保新产品在研发阶段就符合质量要求；
Participate in the quality planning of new product development projects, providing professional opinions and suggestions on product design, process selection, and raw material procurement from a quality perspective to ensure compliance with quality requirements during the R&D phase.
11. 负责组织相关人员实施公司内部审核和管理评审；
Responsible for organizing internal audits and management reviews within the company.
12. 负责迎接外部审核机构包括各认证机构及客户的审核和现场检查工作，如医疗器械质量管理体系的认证审核，积极配合审核工作，及时提供相关资料和信息，确保企业顺利通过审核和认证;
Responsible for coordinating external audits and on-site inspections by certification bodies and customers, such as certification audits of the medical device quality management system. Actively cooperate with audit activities, provide relevant documentation and information in a timely manner, and ensure the company passes audits and certifications smoothly.
13. 负责部门的日常管理工作，指导、培训、评估和激励部门员工，提高部门整体工作效率和氛围；
Responsible for the daily management of the department, including guiding, training, evaluating, and motivating department staff to improve overall departmental efficiency and morale.
14. 完成上级领导安排的其它工作。
Complete other tasks assigned by senior management.
【任职要求】
1. 有8年及以上医疗器械生产企业行业质量管理工作经验
Have more than 8 years of work experience in quality management within the medical device manufacturing enterprise industry.
2. 统招本科及以上学历，医学、药学、生物、医疗器械、机械电子、质量管理等相关专业。
University bachelor's degree or above, with majors in medicine, biology, medical devices, mechanical electronics, quality management, or related fields.