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