Tin tức

Job Responsibilities

1. Fully lead the planning, implementation, and execution of the company’s quality management system, responsible for the adequacy, appropriateness, and effectiveness of the quality management system;

2. Responsible for organizing and implementing risk identification, evaluation, and control activities throughout the product lifecycle;

3. Plan and organize internal and external audits, management reviews, to ensure the effective operation of the ISO13485 and GMP management systems. Promote corrective and preventive measures for non-conformities, guide relevant departments in rectification, and track the effectiveness of measures;

4. Participate in supplier development audits and assessments, guide suppliers to improve quality assurance capabilities. Improve material inspection, process inspection, and finished product inspection specifications and standards;

5. Supervise relevant departments and personnel to implement the standards, regulations, and norms of medical devices, organize or assist in quality management training, and enhance the overall regulatory awareness and management level of the company;

6. Management of system document issuance, modification, retrieval, and external borrowing;

7. Assist superiors in completing other necessary tasks.

Job Requirements

1. Bachelor’s degree or above, majoring in mechanical, electrical electronics, automation, software, or related fields;

2. Proficient in GMP medical device quality management specifications and related regulations, ISO13485 system standards, and hold an internal auditor certificate;

3. More than 8 years of experience in quality control and system establishment related to medical devices, with the ability to work independently;

4. Familiar with the characteristics and inspection standards of various materials such as electronics, structures, and plastics;

5. Rich experience in handling exceptions and supplier guidance, with certain risk assessment capabilities;

6. Good leadership and management skills, judgment, and decision-making abilities;

7. Experience with Class III active medical device products is preferred.

Work Location

Suzhou, Shanghai