质量体系专员

该职位来源于猎聘 主要职责 Key Responsibilities

• 协助主管维护和推动质量管理体系的运行与改善,并对公司质量体系运行情况进行监督；负责集团体系文件的转化。

Assist supervisors in maintaining and promoting the operation and continuous improvement of the quality management system (QMS), supervise the operation status of the corporate QMS; be responsible for the localization and conversion of group-level system documents. 2.支持文件控制和管理。

Provide support for document control and management activities 3.支持定期组织进行质量管理体系的内部审核及内审不合格项的跟踪。

Support the regular organization of internal audits of the quality management system, and follow up on nonconformities identified during internal audits. 4.支持质量体系相关的外部审核并对不合格项进行跟踪。

Support external audits related to the quality management system, and conduct follow-up on audit nonconformities. 5.支持管理评审的实施及改进项的跟踪落实。

Support the implementation of management reviews, and track and complete all improvement items arising therefrom. 6.支持产品上市后监督工作：如负责不良事件的上报、定期风险评价报告、上市后监管计划及报告的编写。

Support post-market surveillance activities of medical devices: including adverse event reporting, preparation of periodic risk evaluation reports, post-market surveillance plans and relevant reports. 7.协助开展质量管理培训。

Assist in organizing and delivering quality management training programs. 8.支持质量数据的收集、分析和评审。

Support the collection, analysis and review of quality-related data. 9.负责提供新产品开发过程中的体系支持。

Provide QMS support throughout the new product development lifecycle. 10.完成领导临时交办的其他工作。

Complete Other Ad-hoc Tasks Assigned By Supervisors. 任职要求 Job Qualifications

• 知识/教育背景 Knowledge / Education：专科及以上学历。College Diploma degree or above. 2.经验与技能要求 Experience and Skill：

至少1年在医疗器械生产企业相关工作经验。生物医学工程、英语专业可放宽工作经验要求。 熟悉医疗器械生产质量管理规范ISO 13485法规标准要求；若有MDR/MDSAP经验优先考虑。 At least 1 year of relevant working experience in a medical device manufacturer. Candidates majored in Biomedical Engineering or English may be exempted from the work experience requirement.Familiar with the requirements of Medical Device Good Manufacturing Practice (GMP) and ISO 13485 regulatory standards; candidates with MDR or MDSAP experience are preferred. 3.资质 Qualification/Credential： 具备ISO 13485 内审员证书优先考虑。Candidates holding an ISO 13485 Internal Auditor Certificate are preferred. 4.语言能力 Language： 具备良好的英语读写能力。Good English reading and writing ability.

• 其他要求 Other Requirements： 具有较强的沟通能力，对工作认真负责、严谨细致、具有团队合作精神。 Possess strong communication skills, work conscientiously, rigorously and meticulously, and demonstrate good teamwork spirit.