Quality TS Lead - China

Baxter

  • 上海市
  • 长期
  • 全职
  • 29天前
Vantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.Essential Duties and Responsibilities
  • Quality support to Field Service operation activities in China
  • Quality support to Service Center operation in China
  • Global Services Quality Systems Local Process Ownership: documentation, procedures, training, internal and external audit, CAPA and non-conformities, post marketing surveillance activities (product complaints, medical device vigilance, and Field Actions), supplier qualification, validation process (IQ, OQ, PQ protocols), change control process and risk assessment
  • Support and ensure compliance of field and service center operations processes in China: Device Release, Labelling, Storage areas, Calibration, Decontamination, Equipment Validations, Repair, PM, Spare parts management
  • Quality KPIs- trending and actions (use of TS systems)
  • Local QMR for Technical Service China
  • Support and /or lead local / regional Service QA projects / initiatives as required.
Education
  • The function requires a Bachelor degree in electrical/electronic engineering or equivalent degree in the technical / technology field
Experience
  • Number of years of experience:
  • Minimum 1-3 years experience in quality management in a medical device or technical service organization – quality processes related to service activity
  • OR experience in technical service/ manufacturing environment
Field of expertise:
  • Medical Device or Electro-mechanical products
Functional/specific competencies
  • Quality System and Quality Assurance knowledge in operations
  • Ability to manage with different tasks in an international environment
  • Ability & willingness to travel
Technical skills
  • Knowledge of Technical Service processes
  • Ability to understand and troubleshoot technical systems
  • Computer literate; able to self learn computer applications
Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .

Baxter