Quality and Compliance Expert

3 weeks ago


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

About the Role

We are seeking a highly skilled Quality and Compliance Expert to join our team at Siemens Healthineers Digital Technology (Shanghai) Co., Ltd. This role will be responsible for providing quality support to our operational activities in APJ & CHN, particularly for Machine Learning (ML) topics.

Key Responsibilities

  • Provide quality support to APJ & CHN operational activities, especially for ML topics
  • Offer new and updated regulation guidance with a regional focus, handle 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
  • Act as a QT project representative for ML global projects, e.g., 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 and above in a biomedical, medical, technical, or management field
  • ISO 13485 auditor or equivalent certification


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