Develop and maintain a robust quality system to ensure regulatory compliance and continuous improvement.
Supports region specific manufacturing registrations
Guides team members on the implementation of the quality system requirements.
Minimum Qualifications
Bachelor’s Degree, or equivalent experience.
7-10 years of experience in Quality Management Systems supporting Medical Devices.
Extensive experience in managing, maintaining and implementing quality management systems
Excellent written and verbal communication skills
Strong customer service orientation and corresponding skills
Excellent interpersonal skills working across multiple divisions
Attention to detail, well organized and time efficient
Can multi-task and work independently
Knowledge of domestic medical device regulatory requirements (China GMP)
Technical writing skills
Proficient in English both oral and written
Experience leading and managing regulatory audits
Preferred Qualifications
Knowledge of international medical device regulatory requirements