China Quality Assurance Manager --某法资医疗耗材公司


Job description


China Quality Assurance Manager


ReportingtoGM– China, and dotted line to Asia QA/RA Manager.


II.Main missions


II.1 QA - China


· Establish the quality management system, guide and supervise the implementation of the system, maintain and improve on the system documentation


· Collect the laws and regulations on medical device operation and supervision, file management of the regulations, supervise the implementation of laws and regulations


· Examine the production and/or operation qualifications of suppliers (suppliers of products, suppliers of services)


· Examine the qualification documents of importer, 3rdparty logistics, distributors and sub-distributors


· Perform on-site inspection to importer and 3rdparty logistics per quarter


· Identify unqualified medical devices and supervise their disposal process


· Collect, investigate and report quality complaints and quality incidents


· Collect, investigate and report adverse events


· Manage product recalls


· Develop and implement efficient procedures that effectively promote compliance, analyzing quality data and results on an ongoing basis to identify quality issues and trends.


· Promptly and proactively communicate issues and initiating actions to drive continuous improvement; reporting and escalating issues to management as per applicable policies


· Creating and maintaining accurate inspection-ready records, files, and reports to conform to policies, procedures, good documentation practices, regulations and quality standards


· Organize quality management training


· Manage self-assessment as well as inspections by Health Authorities


· Manage the post-market surveillance of medical devices, OTC drugs, health foods and cosmetics for China (coordination with HQ and HCP)


II.2 Quality Management of the Finished Good Suppliers


· Manages the quality aspects in the development, sourcing and supply of products with Chinese purchaser in Asia (China and South Eastern Asia)


o Audits of the supplier and/or subcontractor


o Follow-up of the corrective action plans


o Implementation and maintenance of the quality agreement and technical specifications for Asian countries


o Assistance of Mother Companies for development and maintenance of quality agreements and technical specifications for Mother Companies’ products manufactured by these suppliers


· Development of a table for follow up of these suppliers and KPI for reporting to Asia QA/RA Manager, and Quality Head of Mother Companies


· Implementation of practices for qualification of suppliers located in Asia (China and South Eastern Asia)


III.Required skills and competencies


·Key technical skills


· Knowledge of the ISO 13485, GMP, and MDD93/42 EEC, MMD2007/47 Quality Systems


· Fundamental knowledge of the regulatory requirements for Medical Devices (priority), drugs, dietary supplements, cosmetics.


· University degree from Pharmacy, Biology, Chemistry and Chemical engineering.


· Minimum 8 years of experience in the field of medical devices or pharmacy


· Good knowledge of regulations, experience in quality systems and clinical studies will be appreciated


· Key behavior skills


· Rigor, preciseness


· Dynamism, social and relation skills


· Leadership


· Self-driven


· Cross-cultural abilities


· Language: English mandatory