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Company Profile
QA Manager (Shanghai)
Job Responsibilities:
1. Responsible for the establishment and monitoring of product quality objectives throughout the product life cycle
2. Responsible for product quality assurance in the whole life cycle of products, including design and development, raw material procurement, production process and all stages after product launch
3. Guide and implement product verification during the design and development stage and design change stage, including the formulation and review of verification schemes, the establishment and evaluation of test methods, the review of verification reports, etc., supervise the design control, and ensure the quality of product design
5. Managed and supervised the quality management activities in the production process to ensure the compliance and quality compliance of the production process
6. Guide and manage supplier quality related work
7. Maintained post-listing supervision system, managed product quality complaints, adverse events and recall related work
8. Participate in the handling of major product quality problems
9. Supervised and guided the implementation of product CAPA and promoted product quality improvement activities
10. Responsible for related processes of product quality management, promote the improvement and optimization of related working processes
11. Participated in design and development and product optimization process as quality engineering expert, and participated in product risk management process
Manage QA team
12. Maintain good communication and cooperation with external regulatory units and testing institutions
Job Requirements:
1. Bachelor degree or above, major in mechanical, material, chemistry, biology, engineering or science
2. More than 5 years of medical device quality management experience, including more than 3 years of design verification or testing experience, or more than 3 years of production and post-market quality management experience, full life cycle product quality management experience is preferred, sterile medical device industry experience is preferred, team management experience is preferred
3. Familiar with ISO13485 quality management system standard, Chinese GMP requirements and relevant regulations on medical devices, with ISO13485 internal auditor certificate
4. Proficient in MS Office, familiar with quality statistical analysis tools, with certain English listening, speaking, reading and writing skills
5, registered quality engineer, Six Sigma Black belt qualification is preferred
6. Have good leadership, systematic thinking ability, good organization, coordination and problem solving ability