任务/ 职位简述 Mission/ Position Headline： 负责IVD产品的设计开发阶段的质量管理，跨部门合作推进产品在国内成功注册与商业化生产。 包括但不限于：设计控制、工艺验证、产品放行、上市后监管（不良事件、定期风险评价报告等） ，内部和外部审计。 Responsible for quality management of IVD products during the design and development phase, and cross-departmental cooperation to promote the successful registration and commercialization of products in China. Including but not limited to: design control, process validation, product release, post-marketing surveillance (adverse events, periodic risk evaluation reports etc.), internal and external audits. 职责领域 Areas of Responsibilties:： - 负责确保IVD产品的设计/生产转移活动，以满足国内药监局（NMPA）等设计控制要求。 - 主导风险管理活动，包括推动风险管理档案的建立、审查和更新。 - 负责原材料、工艺和成品等过程的不合格/偏差/变更/CAPA，并协调当地质量评审委员会的活动。 - 负责为生产、技术、工程等其他跨职能团队提供质量保证支持，确保各项活动符合质量管理体系要求和国内法规等要求。 - 负责提供质量法规或产品知识技能等培训， 以提高员工的质量法规意识与技能水平。 - 负责支持产品拟上市与生产许可证的审核准备，以及现场审核和后续整改的支持工作。 - 负责产品的最终放行。 - 负责产品上市后监管活动，包括产品投诉、忠告性通知/产品信息告知、不良事件报告（含定期风险评价报告）、召回等。 - 负责完成上级或公司指派的其他相关项目或任务。 - Responsible for ensuring design/manufacturing transfer activities for IVD products to meet design control requirements such as the National Medical Products Agency (NMPA). - Lead risk management activities including driving the creation, review and update of risk management files. - Responsible for nonconformities/deviations/changes/ CAPAs for processes such as raw materials, processes and finished products, and coordinates the activities of the local Quality Review Board. - Responsible for providing quality assurance support to other cross-functional teams such as production, technology, engineering, etc. to ensure that activities are in compliance with QMS requirements and domestic regulations, etc. - Responsible for providing training on quality regulations or product knowledge and skills to improve employees' awareness of quality regulations and skills. - Responsible for supporting the preparation of products to be marketed and production license audits, as well as on-site audits and subsequent corrective actions. - Responsible for final product release. - Responsible for post-market regulatory activities, including product complaints, advisory notices/product information notification, adverse event reports (including periodic risk assessment reports), recalls, etc. - Responsible for completing other related projects or tasks assigned by supervisor or the company. 经验Experience • 从事医疗器械（IVD）质量工作至少 8年，其中至少 2 年为QA经验，主要知识包括设计控制、风险管理和变更管理。Minimum of 8 years in medical device (IVD) quality with at least 2 years of QA experience with key knowledge in design control, risk management and change management. • 在设计开发、风险管理和变更管理、以及解决化学发光试剂产品技术问题等方面，拥有丰富的能力与经验。Extensive capabilities and experience in design development, risk and change management, and resolving technical issues with chemiluminescent reagent products. • 具有外部审核准备和接待的成功经验，并能协助注册申报资料的准备。 Successful experience in external audit preparation and reception and able to assist in the preparation of registration filings. • 具有第三方组织颁发的ISO13485证书，并参加/主导过内审活动。 Have ISO 13485 certification from a third-party organization and has participated/lead internal audit activities. • 能够分清多任务项目的轻重缓急，在压力下可以良好工作。 Ability to prioritize and juggle multiple projects and thrive under pressure. • 较强的沟通和表达能力。 Strong communication and presentation skills. • 具备良好的英语口语和书面表达能力。 Good oral and written English is required.