Factory Guarantor

Job Responsibilities

1. Responsible for assisting the department in improving quality management systems, reviewing and revising quality management system documents, and implementation;

2. Responsible for quality assurance of medical device product design, development, production and sales process;

3. Participate in the audit of suppliers and establish supplier files to ensure that the materials used for product production are purchased from qualified suppliers;

4. Responsible for the handling of quality assurance elements related to the product realization process, including the handling of non-conforming processes, the formulation and implementation of corrective measures and preventive measures, complaint handling, and quality assurance of production process;

5. Responsible for the supervision of the production site and production process, review batch production records and inspection records, and make review opinions on the release of materials and products;

6. Responsible for assisting the department in dealing with external audits, inspections by regulatory agencies and certification of the corresponding quality systems;

7. Responsible for assisting the department to organize confirmation or verification, develop a confirmation or verification plan, and execute the plan;

8. Responsible for assisting the department in organizing internal audits, management reviews and other quality activities, and keeping relevant records and reports;

9. Other related work.

Job requirements

1. technical secondary degree or above, major in medicine, laboratory science, medical equipment and pharmacy;

2. Familiar with OFFICE working software;

3. Have strong communication skills, have a strong sense of responsibility and teamwork;

4. Internship experience in pharmaceutical and medical device manufacturers is preferred;

5. Master AutoCAD software is preferred.