器械质量助理

岗位职责：
Position Responsibilities:

1、质量体系日常运维（核心）/ Daily QMS Operation & Maintenance (Core)
协助上级搭建、落地与维护医疗器械质量管理体系，严格遵循ISO 13485:2016、欧盟MDR (2017/745)及国内NMPA医疗器械法规要求，配合完成体系全流程合规管控，覆盖研发、采购、委托生产、生产、检验、售后等环节。协助开展内部审核、管理评审，整理体系运行数据，排查基础合规问题，保障体系稳定有效运行。
Assist supervisors in establishing, implementing and maintaining the medical device quality management system (QMS) in accordance with ISO 13485:2016, EU MDR (2017/745) and NMPA regulations. Support full-process compliance management covering R&D, procurement, entrusted manufacturing, production, inspection and after-sales. Assist in internal audits and management reviews, sort out system operation data, identify basic compliance risks, and ensure stable and effective system operation.
2、体系文件管控与更新 / QMS Document Control & Update
协助编制、修订、归档、发放质量手册、程序文件、作业指导书及各类质量记录，同步跟进ISO13485、MDR最新法规更新，确保文件合规、版本统一、可追溯。负责日常体系文件台账管理、借阅管控、过期文件回收销毁，规范文件全生命周期管理。
Assist in compiling, revising, filing and issuing quality manuals, procedure documents, SOPs and quality records. Follow up the latest updates of ISO 13485 and MDR regulations to ensure document compliance, version consistency and traceability. Responsible for daily document ledger management, borrowing control and expired document disposal to standardize the full life cycle of QMS documents.
3、审核协助与整改落地 / Audit Support & Rectification Tracking
配合对接药监飞检、第三方ISO13485审核、MDR合规审核、客户验厂及委托生产供方审核等各类内外部审核。负责审核资料整理、台账梳理、现场配合答疑工作；协助汇总审核不符合项，跟进整改方案落地、CAPA闭环验证，整理输出整改报告，沉淀整改经验。
Support internal and external audits including NMPA unannounced inspections, third-party ISO 13485 audits, MDR compliance audits, customer factory audits and supplier audits for entrusted manufacturing. Responsible for audit document sorting, ledger collation and on-site coordination. Assist in summarizing non-conformities, tracking the implementation of rectification plans and CAPA closed-loop verification, and compiling rectification reports.
4、基础质量合规管理 / Basic Quality Compliance Management
协助开展质量风险管理、偏差管理、变更管理、不良事件监测、客户投诉处理等基础质量工作，规范流程记录，确保各项质量活动合规闭环。配合完成委托生产日常质量管控、供方资料审核、外协质量记录核查工作。
Support basic quality management work including quality risk management, deviation control, change management, adverse event monitoring and customer complaint handling, standardize process records, and ensure closed-loop management of all quality activities. Assist in daily quality control of entrusted manufacturing, supplier document review and outsourced quality record verification.
5、质量培训与持续改进 / Quality Training & Continuous Improvement
协助组织公司内部质量体系、ISO13485、MDR法规基础知识培训，整理培训资料、做好培训记录。收集日常体系运行问题，协助开展根因分析与流程优化，落地质量持续改进工作。
Assist in organizing internal training on QMS, ISO 13485 and MDR basic knowledge, sort out training materials and records. Collect daily system operation problems, support root cause analysis and process optimization, and promote continuous quality improvement.

任职要求：
Position Requirements :
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、工业工程等理工科相关专业。
Bachelor’s degree or above, major in science and engineering including machinery, electronics, biology, medicine, materials, chemical engineering, industrial engineering and other related fields.
2、工作经验 / Work Experience：无硬性工作经验要求，接受医疗器械相关专业应届毕业生；有医疗器械体系实习经验、ISO13485内审员证书者优先。
No mandatory working experience required. Fresh graduates with medical device-related majors are acceptable. Candidates with medical device QMS internship experience or ISO13485 internal auditor certificate are preferred.
3、核心能力 / Core Competencies
• 了解ISO 13485:2016医疗器械质量管理体系及欧盟MDR法规基础内容，熟悉医疗器械行业基本质量规范；
Basic understanding of ISO 13485:2016 medical device quality management system and EU MDR regulations, familiar with basic quality specifications of the medical device industry.
• 具备良好的文档撰写、数据整理、台账统计能力，熟练使用Office办公软件，细心严谨、执行力强；
Good ability of document writing, data sorting and ledger statistics, proficient in Office software, careful, rigorous and highly executable;
• 学习能力、沟通协调能力良好，服从工作安排，能够快速吸收行业法规与体系知识，适配岗位工作；
Strong learning ability and communication skills, obedient to work arrangements, able to quickly master industry regulations and QMS knowledge;

其他信息：
Additional Information:
• 品行端正、责任心强，具备良好的团队协作意识与职业素养；
Integrity, responsible, with good team spirit and professional ethics;
• 有志于长期深耕医疗器械质量合规领域，愿意持续学习成长。
Willing to develop a long-term career in medical device quality compliance and keep learning.