质量经理

1.Establish quality management system in accordance with the “Medical Device Production Quality Management Standards” and relevant appendices;

2.According to the requirements of the quality management system, manufacture samples and complete registration inspection based on the “Product Technical Requirements”;

3.Ensure that materials, production, and testing meet regulatory and technical requirements;

4.Organize product release audits, implement process audit, layered process audit and other necessary quality audits when assigned;

5.Handle deviations and non-conformities in production. Using the 8D/FMEA methodology to analyze production deviations and drive the implementation of Corrective and Preventive Actions (CAPA).

6.Organize post-market quality management (returns, complaints, adverse event investigations, etc.) and complete the report;

7.Organize annual unannounced inspection;

8.Quality Management in the Production Process;

9.Ensure that quality management personnel are adequately trained. Lead and teach quality employees on the appropriate usage of Part Validation. Establish Part Validation protocols for new production processes;

10.Be responsible for other product quality-related activities.

Education, knowledge and abilities:

1.Bachelor's degree or above in Biomedical Engineering, Mechatronics, or related fields;

2.At least 5 years of quality management experience in medical equipment manufacturing, with a preference for experience with C-arm/X-ray equipment;

3.Good knowledge in GMP, ISO 13485, preferably with an ISO 13485 internal auditor certificate, experienced in leading certification audits, and proficient in using various quality tools;

4.Good skills in problem solving and team work needed;

5.Fluent in English listening, speaking and writing;