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.
Your mission and responsibilities:
1.by coach, main review, training, review, communication, influence, and other necessary skills to the R&D project teams, to make sure the high quality output of products（ including documents） and make sure the compliance with related regulation, standards and customer requirements， and signature and release R&D project and ECO as independent controller.;
通过对研发团队的指导，培训，审核，主评审，沟通，影响和 其它需要之方法， 以实现项目高质量的产品输出（包括文档），同时确保研发活动对法规、标准和客户要求的满足, 并作为独立监管员签署并发布研发产品和设计变更。
2.responsible for risk management of R&D product as risk manager, and signature and release risk documents;
3.Responsible for the control of product defect decision as indepent controller, and also as the releaser of concession and stop delivery;
4.Timely tracking design related regulation( at least including ISO 13485, ISO 9001,QSR 820,China GMP,Australia TGA 1989 and 2002,Brazil ANVISA RDC16/2013,Japan MHLW NO.169 , Canada CMDR ,EU MDD, MDR), analysis and planning of implementation and lead implementation;
及时跟踪全球研发管理相关法规（至少包括ISO 13485, ISO 9001,QSR 820,China GMP,Australia TGA 1989 and 2002,Brazil ANVISA RDC16/2013,Japan MHLW NO.169 , Canada CMDR ,EU MDD, MDR)， 分析并制定执行计划并领导导入计划的执行；
5.Coordination of and contribution to solve quality problems according to e.g. 8D-methodology and drive projects to solve the problems sustainably.
6.Training of internal colleagues with the target to get a solid performance
7. Coach the corresponding team, as the quality mentor and give fully support for all team members
Your qualifications and experiences:
1.Bachelor degree with major in Engineering, Science or Medicine or equal professional background of corresponding competence.
2. 1~3 year of experience in Quality Management
3.Auditing experience in e.g. ISO9001 and Lead Auditor examination
4.Good knowledge of standards - ISO 9001, , IEC 60601, ISO14971, Knowledge of ISO 13485, FDA regulations.
熟知ISO 9001, ISO 14971, IEC 60601, MDR,ISO13485等标准和FDA法规；
5.You have solid experience in application of Q-methods and statistics, e. g. SPC, MSA, APQP.
6. Able to work independently and systematically.
7.Ability of working in high pressure
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.
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.
Organization: Siemens Healthineers
Company: Siemens Shenzhen Magnetic Resonance Ltd.
Experience Level: Experienced Professional
Full / Part time: Full-time