1. Establish, maintain and optimize the Quality Management System continuously according to business requirements, quality regulations and standards, to ensure the quality management system’s effectiveness, efficiency and compliance.
2. Manage new quality regulation phase-in project and regular SOP update, cooperate with Head quarter, organize and follow up the implementation.
3. Manage training orderly, improve the organization quality sense.
4. Prepare and handle the external and internal audits, ensure business unit can pass the external audits smoothly. Push and follow up the findings effectively till their closure.
5. Be responsible for management review and annual quality target setting.
6. Monitor quality management system operation status and generate QMS status report in regular interval.
7. Organize CAPA meeting, push and follow-up CAPAs till their closure.
8. Be Responsible for GMP self check and provide annual report to NMPA.
9. Support PMS, project and registration when necessary
Bachelor degree is required, major in technical (SW, HW, E&E, Medical device related ), project management and/or advance degree is preferred.
At least 6 years of Medical device company working experience.
Certification on ISO13485, in addition QSR820/MDSAP/MDR is a plus.
Experience with quality management system maintained and optimization, internal and external audit, CAPA/NC handling
Experience in design quality control, post market surveillance or project management is a plus.
Experience with TUV audit, FDA audit is a plus.