器械质量经理（高级）

1、质量管理体系优化与维护/ QMS Optimization & Sustaining
全面负责公司医疗器械质量管理体系的改进、落地、迭代优化与日常运维，严格依据ISO 13485:2016医疗器械质量管理体系标准、欧盟MDR (2017/745)法规及国内医疗器械相关监管法规，搭建适配企业产品全生命周期的合规质量体系，覆盖研发、采购、委托生产、检验、仓储、销售、售后、不良事件处理等全流程业务，保障体系持续合规、有效运行。定期开展体系内部审核、管理评审，识别体系运行漏洞，持续优化流程制度，完善质量管控机制。
Fully responsible for the improvement, implementation, iterative optimization and daily operation of the company's medical device quality management system (QMS). In strict accordance with ISO 13485:2016, EU MDR (2017/745) and domestic medical device regulatory requirements, build a full-life-cycle compliant quality system covering R&D, procurement, entrusted manufacturing, inspection, warehousing, sales, after-sales service and adverse event handling. Conduct regular internal audits and management reviews, identify system deficiencies, continuously optimize processes and documents, and improve the overall quality control mechanism to ensure sustained and effective system operation.
2、合规管控与文档管理 / Compliance Control & Document Management
主导质量体系文件（质量手册、程序文件、作业指导书、记录表单）的编制、修订、审核、发布与管控，确保文件与最新ISO13485、MDR及国内药监法规同步更新。负责欧盟MDR合规管控，熟悉CE认证、技术文件、PRRC合规要求，保障出口医疗器械产品合规性，规避海外合规风险。统筹企业质量风险管理、偏差管理、变更管理、CAPA闭环管理，规范各类质量异常处理流程。
Lead the compilation, revision, review, issuance and control of QMS documents including quality manuals, procedure documents, SOPs and records, ensuring full alignment with the latest ISO 13485, MDR and NMPA regulations. Take charge of EU MDR compliance management, familiar with CE certification, technical documentation and PRRC requirements to ensure the compliance of exported medical devices and avoid overseas regulatory risks. Overall manage quality risk management, deviation control, change management and CAPA closed-loop management, and standardize the handling process of all quality non-conformities.
3、审核对接与整改落地 / Audit Management & Corrective Action Implementation
全权负责各类内外部审核对接工作，包含药监飞检、第三方认证机构ISO13485审核、欧盟MDR审核、委托生产供方审核等。全程主导审核筹备、现场对接、问题答疑、资料举证工作；针对审核发现的不符合项，牵头制定整改方案、明确整改责任人与节点，全程跟踪推进整改落地、验证闭环，输出完整整改报告，杜绝同类问题重复发生。
Take full charge of internal and external audits, including NMPA unannounced inspections, third-party ISO 13485 certification audits, EU MDR audits, and supplier audits for entrusted manufacturing. Lead audit preparation, on-site reception, inquiry response and document provision. For non-conformities identified in audits, formulate rectification plans, clarify responsible persons and time nodes, track and verify the full closed-loop implementation of corrective actions, deliver complete rectification reports, and prevent recurrence of similar quality problems.
4、委托生产质量管控/ Contracting Manufacturing Quality Control
负责医疗器械委托生产全流程质量管理，建立完善的受托方准入、审核、考评、动态管控体系。定期开展受托工厂现场稽核、体系核查与质量巡检，管控委托生产来料、制程、成品质量，审核委托生产相关质量文件与记录，协调解决委托生产过程中的质量异常与合规问题，保障委托生产产品质量稳定、合规可控。
Manage the full-process quality management of medical device entrusted manufacturing. Establish a complete dynamic management system for supplier access, audit and performance evaluation. Conduct regular on-site inspections, system verification and quality patrols for entrusted manufacturers. Control the incoming material, in-process and finished product quality of outsourced production, review relevant quality documents and records, coordinate and resolve quality and compliance issues during entrusted manufacturing, to ensure stable quality and full compliance of outsourced products.
5、质量培训Quality Training
组织开展全员质量体系、ISO13485、MDR法规及质量实操技能培训，强化全员合规质量意识，提升整体质量管控水平。定期输出质量数据分析报告、体系运行报告，为公司质量决策提供依据。
Organize company-wide training on QMS, ISO 13485, MDR regulations and practical quality operation skills to strengthen staff compliance awareness and improve overall quality management capability. Regularly issue quality data analysis reports and system operation reports to support company quality decision-making.
6、质量持续改进 / Continuous Quality Improvement
收集行业最新医疗器械法规、标准更新信息，及时落地合规升级工作。针对生产、运营、客户反馈的质量问题，牵头开展根因分析，推动流程优化、工艺改进、体系升级，持续降低质量风险、提升产品质量与企业合规管理水平。
Track the latest updates of medical device regulations and industry standards, and implement timely compliance upgrades. Lead root cause analysis for quality problems from production, operation and customer feedback, promote process optimization, process improvement and system upgrading, so as to continuously reduce quality risks and improve product quality and enterprise compliance management level.

任职要求：
Position Requirements:
1、 学历专业 / Education & Major：
本科及以上学历，机械、电子、生物、医学、材料、化工等理工科相关专业。
Bachelor’s degree or above, major in science and engineering including machinery, electronics, biology, medicine, materials, chemical engineering and other related fields.
2、工作经验 / Work Experience：
5年及以上医疗器械行业质量管理工作经验，3年及以上质量团队管理经验；高级质量经理优先录用8年以上相关工作经验、丰富体系搭建与审核整改经验者。
At least 5 years of quality management experience in the medical device industry, with more than 3 years of team management experience. Candidates with 8+ years of relevant experience and rich experience in QMS establishment and audit rectification are preferred for Senior Quality Manager position.
3、核心能力 / Core Competencies
• 精通ISO 13485:2016医疗器械质量管理体系，熟练掌握欧盟MDR法规核心要求，熟悉国内医疗器械监督管理条例及配套法规，具备独立搭建、优化、运维质量体系的能力；
Proficient in ISO 13485:2016 medical device quality management system and core requirements of EU MDR regulations, familiar with domestic medical device supervision regulations, capable of independently establishing, optimizing and maintaining QMS;
• 具备丰富的内外部审核应对经验，成功主导过药监审核、第三方体系认证、客户验厂及MDR相关审核，擅长问题整改、CAPA闭环管理，审核零重大缺陷者优先；
Rich experience in handling internal and external audits, including NMPA inspections, third-party certification, customer audits and MDR audits; skilled in problem rectification and CAPA closed-loop management; candidates with zero major audit non-conformities are preferred;
• 具备医疗器械委托生产质量管理经验优先，熟悉委托生产、供方管控、供应商审核流程；
Experience in contracting manufacturing quality management of medical devices is highly preferred; familiar with contract manufacturing, supplier management and supplier audit;
• 熟练掌握医疗器械质量风险管理、变更、偏差、不良事件、投诉处理等核心质量模块工作，能独立完成体系文件编制、评审、更新工作；
Familiar with core quality modules including quality risk management, change control, deviation handling, adverse event management and complaint handling; able to independently complete QMS document compilation, review and revision;
• 具备良好的数据分析、问题复盘、统筹协调能力，逻辑清晰、责任心强，抗压能力优秀，可独立统筹重大质量及审核专项工作。
Excellent in data analysis, problem review and overall coordination; logical, responsible and stress-resistant; capable of independently managing major quality and audit projects.

其他信息：
Additional Information:
• 熟悉医疗器械产品全生命周期质量管理逻辑，有出口医疗器械合规管理经验者优先；
Familiar with full-life-cycle quality management of medical devices; experience in export medical device compliance management is preferred;
• 具备优秀的团队管理、沟通协调、公文撰写能力，严谨细致、执行力强；
Excellent team management, communication and document writing skills; rigorous, detailed and highly executable;