任务/职位简述 Mission/Position Headline： 执行总体质量任务和战略，并确保所有分配的质量领域的相关质量方针和指导的实施。Implements overarching Quality mission and strategy, and ensures implementation of related Quality policies and guidelines, for all assigned quality areas.
职责领域 Areas of Responsibilties:：
61 确保上海工厂质量体系的实施和改进，包括质量保证（如文件、培训、内部审核等）和质量工程（如CAPA、不合格品管理、工艺验证等）。Ensures implementation and improvement of Shanghai facility quality system, including Quality Assurance (e.g., Documentation, Training, Internal Audit, etc.) and Quality Engineering (e.g. CAPA, Nonconformance management etc.).
61 担任上海工厂质量体系管理者代表，在外部质量体系核查时作为代表参与现场核查。Serve as the Shanghai Quality System Management Representative and represent the site during external regulatory inspections.
61 与各职能部门沟通，在产品生命周期中提供法规指导，包括质量管理体系要求，标签要求、注册要求，注册时限以及监管机构的期望。Interface with a variety of functional groups to provide regulatory guidance regarding the management of issues throughout the product life cycle, including QMS requirements, labeling requirements, registration requirements and timing, and expectations of the regulatory bodies.
61 收集相关法规和标准信息，及时了解政策趋势。Collect related regulation and standard information, keep update on local trend and policy.
61 雇佣、培训和发展上海相关质量和注册团队。Hire, train and develop the Shanghai-based related Quality and regulatory team.
61 其他上级或公司交代的项目或任务。
Other related projects or tasks assigned by superior or company.
经验Experience
61 至少8年以上医疗器械和/或药品行业工作经验，有IVDD\CE\FDA经验者优先考虑。A minimum of 8 years in the medical device and/or pharmaceutical industry with at least 5 years in a quality system management role . Prior IVDD\CE\FDA experience highly desired.
61 Be familiar with the regulations of medical devices, have the experience in quality management, and have strong capability to handle the problem in production management and quality management
熟悉医疗器械法律法规，具有质量管理的实践经验，有能力对生产管理和质量管理中的实际问题作出正确的判断和处理。
61 Have the knowledge of medicine, laboratory science, biology, immunology or pharmacy with the practical experience
61 应当具有医学、检验学、生物学、免疫学或药学等相关的专业知识，并具有相应的实践经验。
61 有接待/参与质量体系核查的经验，如NMPA、公告机构。Experience in hosting/participating in quality system inspections, e.g., CFDA, Notified Bodies.
61 有质量体系审核经验，如有IVDD制造商经验优先考虑。Quality system auditing experience and prior experience in an IVDD manufacturing environment is preferred.
61 有工厂建立和质量体系实施经验者优先考虑。Prior experience with facility start-ups and quality system implementation is a plus.
61 与上海市药品监督管理局有直接联系并与国家药品监督管理局保持良好联系者优先考虑。Direct hands on experience and relationship with Shanghai FDA and good contact with NMPA will be plus.
61 至少5年管理经验并具备人力发展能力。At least 5 years of management experience and demonstrated competence in personnel development.
61 开放性思维和良好的团队建设和领导力。Open-mind and Strong team building and leadership skills.
61 具备识别优先级以及同时处理多个任务的能力，抗压能力强。Ability to prioritize and juggle multiple projects and thrive under pressure.
61 较强的沟通和表达能力。Strong communication and presentation skills.
61 良好的英语口语和书面表达能力。Good oral and written English is required.
教育Education
61 本科以上学历，生物学、生物医学工程、医学、工程或科学学科相关专业。Bachelor degree or above, major in biology, biomedical engineering, medicine, engineering or science discipline related.