Quality TS Lead - China
Baxter
- 上海市
- 长期
- 全职
- 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.
- The function requires a Bachelor degree in electrical/electronic engineering or equivalent degree in the technical / technology field
- 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
- Medical Device or Electro-mechanical products
- Quality System and Quality Assurance knowledge in operations
- Ability to manage with different tasks in an international environment
- Ability & willingness to travel
- Knowledge of Technical Service processes
- Ability to understand and troubleshoot technical systems
- Computer literate; able to self learn computer applications