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SSME XP Senior Quality Engineer

Job Description

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. Sound interesting?


Take Quality Assurance roles within whole product life cycle.

  • Quality Assurance:
  • stablishment/maintenance for Device marketing, design and development, manufacturing, according to business requirements and international quality regulations.
  • Ensure that product engineering process (PEP) is strictly followed by project team and all quality requirements are fulfilled.  Work closely with project team and provide process supports to project/product team, participate in the review and evaluation on relevant documentation coming from different milestones of project/product development.
  • Supervise the change control process is properly followed within design or manufacturing process change, responsible for the change plan approval, document review, and final release the changes within whole product life cycle.
  • Monitor manufacturing quality, initiate data analysis, support corrective and preventive actions if necessary. Exchange information with DCU, timely raised potential trend issues to CCB.
  • Participate and handle the internal/external audits, initiate and follow-up the continuous improvements.

Experience:

•    More than 5 years experiences with quality management in medical industry.

•    Bachelor’s degree or above on engineering.

•    Knowledge of quality standard such as ISO13485, MDR, CGMP, QSR820.

•    Good Experience with processes/quality control for new product development project.

•    Good in written and spoken English and Mandarin.

•    Good team work as well as self-development.



Organization: Siemens Healthineers

Company: Siemens Shanghai Medical Equipment Ltd.

Experience Level: Experienced Professional

Full / Part time: Full-time

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