SHDM Quality Head
Siemens
Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
职责领域 Areas of Responsibilties:： • 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.). • 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.• 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.• 负责中国的整体注册流程，包括NMPA法规要求的解释、注册活动的策划和实施，以及在中国成功注册产品所需的其他活动。Be accountable for overall registration process in China inclusive of NMPA regulation requirement interpretation, registration activities planning and implementation, other activities necessary for successful registration of products in China.• 负责质量团队以及注册任务的资源规划，并指导相关人员开展各种活动。Be accountable for resource planning for related Quality team and registration activities and direct related staff to run different activities.• 与地方药监局保持联系，及时向主管当局提交必要的注册材料以及体系资料，并与主管当局保持联系以确保产品快速、及时的获批。Work as liaison to local authority, timely deliver all necessary registration and QMS materials to authorities and follow up with authority to ensure rapid and timely approval of the product.• 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.• 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.• 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• 至少8年以上医疗器械和/或药品行业工作经验，至少5年质量体系管理和法规注册工作经验。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 and registration experience. Prior IVDD\CE\FDA experience highly desired.• 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。• Have the knowledge of medicine, laboratory science, biology, immunology or pharmacy with the practical experience• 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。• 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.• 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.• 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.• 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.• 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. • 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.• 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.• 较强的沟通和表达能力。Strong communication and presentation skills. • 良好的英语口语和书面表达能力。Good oral and written English is required.
教育Education• 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.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture:We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.As an equal opportunity employer, we welcome applications from individuals with disabilities.We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.
To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
职责领域 Areas of Responsibilties:： • 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.). • 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.• 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.• 负责中国的整体注册流程，包括NMPA法规要求的解释、注册活动的策划和实施，以及在中国成功注册产品所需的其他活动。Be accountable for overall registration process in China inclusive of NMPA regulation requirement interpretation, registration activities planning and implementation, other activities necessary for successful registration of products in China.• 负责质量团队以及注册任务的资源规划，并指导相关人员开展各种活动。Be accountable for resource planning for related Quality team and registration activities and direct related staff to run different activities.• 与地方药监局保持联系，及时向主管当局提交必要的注册材料以及体系资料，并与主管当局保持联系以确保产品快速、及时的获批。Work as liaison to local authority, timely deliver all necessary registration and QMS materials to authorities and follow up with authority to ensure rapid and timely approval of the product.• 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.• 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.• 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• 至少8年以上医疗器械和/或药品行业工作经验，至少5年质量体系管理和法规注册工作经验。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 and registration experience. Prior IVDD\CE\FDA experience highly desired.• 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。• Have the knowledge of medicine, laboratory science, biology, immunology or pharmacy with the practical experience• 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。• 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.• 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.• 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.• 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.• 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. • 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.• 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.• 较强的沟通和表达能力。Strong communication and presentation skills. • 良好的英语口语和书面表达能力。Good oral and written English is required.
教育Education• 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.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture:We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.As an equal opportunity employer, we welcome applications from individuals with disabilities.We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.
To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
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