CS Quality Assurance Manager

5 days ago

Shanghai, Shanghai, China Siemens Healthineers Digital Technology (Shanghai) Co., Ltd. Full time
Quality Manager for Medical Devices

We are seeking a highly skilled Quality Manager to join our team at Siemens Healthineers Digital Technology (Shanghai) Co., Ltd. in Shanghai, China. As a Quality Manager, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Provide quality support for APJ & CHN operational activities, with a focus on medical device topics.
  • Develop and implement new and updated regulation guidance with a regional focus, handling escalations related to quality compliance.
  • Drive the implementation of global initiatives and requirements, closely aligned with CS QT global and relevant counterparts within local QT teams.
  • Support corrective and preventive actions, as well as improvement projects.
  • Support the implementation and maintenance of regulatory/quality requirements at ML warehouses, including regular walk-throughs and follow-up.
  • Contribute to supplier management activities and perform supplier audits.
  • Represent the QT project for ML global projects, such as P58 or Spe-2-ed.
  • Support the global CS ML QT representative with global tasks (region-independent).
Requirements:
  • At least 5 years of operational responsibilities in the healthcare industry.
  • At least 3 years of experience in quality and process management.
  • Project management experience is preferred.
  • Supply Chain Management or logistics management experience is preferred.
  • International study and work experience is preferred.
  • Bachelor's degree or above in a biomedical, medical, technical, or management field.
  • ISO 13485 auditor or equivalent certification.
About Us:

We are a global 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.

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