Main Tasks & Responsibilities主要工作职责 :
1. Be responsible for quality assurance work for product commercialization, including support product development team with design and development activities in compliance with applicable regulatory，standards and design control processes in product lifecycle, provide product development team coaching or training with applicable regulation, standards and processes, guide development team during product development planning, review and approve design and development deliverables, review and approve product changes.
负责公司产品商业化的质量保证活动，包括在产品生命周期中支持产品开发团队开展符合适用法规、标准要求与设计控制流程要求的设计开发活动，为产品开发团队提供设计控制流程、适用医疗器械法规、标准的咨询或培训， 指导开发团队进行产品开发过程定义与策划， 审核设计开发交付件， 评审、批准产品变更。
2. As the quality representative of the product localization project, participate in the review of deliverables and relevant project meetings to ensure that the deliverables comply with Roche headquarters and local quality regulations and meet the company's business needs.
作为产品本地化项目的质量代表参与产品生产转移过程中各阶段交付成果的评审和相关项目会议，确保交付成果符合罗氏总部及当地的质量法规要求，并符合公司业务需求。
3. Participate in quality management activities during the product life cycle of the MAH and software products, including product change management, quality monitoring with entrusted manufacturing companies, product release and review and closure of NC/CAPA/SCAR.
参与注册人制度产品和独立软件产品生命周期内的质量管理活动，主要包括产品变更管理，对受托生产企业的质量监控，产品上市放行及NC/CAPA/SCAR的评审和关闭。
4. Communicate, train and monitor local implementation of applicable local regulatory requirements and global Standards，and assist in the establishment and maintenance of GMP-related quality systems.
沟通、培训、监测本地法规和总部质量标准在当地的执行并协助GMP相关质量体系的建立和维护工作。
5. Quality Documents & Records Control and Change Control. Keep records. Have clear filing and maintenance of all documents.
质量文件、记录的控制及变更文件的控制。文件分类归档，保留完好。
6. Coordinate and support for External Audit, Internal Audit.
协助及支持完成公司内部及外部的质量方面的审核工作。
7. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
遵循罗氏所有合规要求，包括但不限于罗氏信息安全，罗氏商业中的行为，罗氏竞争法互动对话，罗氏安全健康环境等，合法合理开展业务活动。
8. Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook).
了解并执行直线经理的SHE职责（详见SHE手册相关定义）。
Education & Qualifications教育背景与专业资格:
1. Bachelor degree or above in medical equipment / mechanics / automation / computer / electronics / electrical / bioengineering / medicine / biochemistry / clinical examination, etc.
医疗器械/机械/自动化/计算机/电子/电气/生物工程/医学/生化/临床检验等本科以上学历。
2. Proficiency in both spoken and written English.
熟练掌握英语口语及书面表达。
3. Good command of MS office software application.
熟练应用微软办公软件。
4. Understand medical device/drug regulation.
了解医疗器械/药品法规.
Experience工作经验:
More than 2 years of experience in medical device production quality management, familiar with ISO13485 management system, GMP and other regulations. Experience in quality management of new medical device product development or localization projects is preferred.
2年以上医疗器械生产质量管理管理工作经验，熟悉ISO13485管理体系、GMP等法规。医疗器械新产品开发或本地化项目质量管理工作经验者尤佳。