Senior Quality Assurance Manager for Medical Devices

4 weeks ago


Shanghai, Shanghai, China Siemens Healthineers Digital Technology (Shanghai) Co., Ltd. Full time

We are seeking an experienced Senior Quality Assurance Manager to join our team at Siemens Healthineers Digital Technology (Shanghai) Co., Ltd. in Shanghai, China.

About the Role

This is a unique opportunity to lead quality assurance initiatives and support operational activities in APJ & CHN regions, focusing on ML topics. You will be responsible for providing quality support, driving implementation of global initiatives, and ensuring compliance with regulatory requirements.

The ideal candidate will have at least 5 years of operational responsibilities in the healthcare industry, with experience in quality and process management, project management, and supply chain management.

Key Responsibilities
  • Provide quality support to APJ & CHN operational activities, especially for ML topics
  • Develop and implement new and updated regulation guidance with regional focus, handle escalations related to quality compliance, and drive implementation of global initiatives
  • Support corrective and preventive actions as well as improvement projects, and ensure compliance with regulatory requirements at ML warehouses
  • Contribute to supplier management activities, perform supplier audits, and support QT project representatives for ML global projects
Requirements
  • At least 5 years of operational responsibilities in the healthcare industry
  • Experience in quality and process management, project management, and supply chain management
  • ISO 13485 auditor or equivalent certification
  • Bachelor degree and above in biomedical, medical, technical, or management fields
Benefits

We offer a competitive salary of RMB 450,000 - 600,000 per year, depending on your qualifications and experience, plus a comprehensive benefits package including health insurance, retirement plan, and paid time off.



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