Job Responsibilities:

1. Responsible for developing and improving the processes and standards related to validation in the company's quality management system, ensuring compliance with regulatory requirements in the medical device industry (such as GMP, FDA, ISO13485, etc.);

2. Lead the validation work related to medical device products, including but not limited to process validation, equipment validation, cleaning validation, software validation, etc. Develop validation plans and organize their implementation;

3. Cooperate with the regulatory department to communicate with external regulatory agencies, clients, etc., welcome inspection work, and provide relevant verification materials and information;

4. Coordinate cross departmental resources (such as technology, regulations, production, engineering, etc.) to ensure that the validation project progresses according to plan and promptly resolve any issues that arise during the validation process.

Job Requirements:

1. Bachelor's degree or above, with a preference for majors in medical devices, pharmacy, bioengineering, quality management, or related fields;

2. Ability to read English regulatory documents (such as FDA guidelines), proficient in writing Chinese and English validation documents is preferred;

3. More than 3 years of QA or verification related work experience in the medical device industry, with at least 1 year of team management experience preferred;

4. Proficient in validation methodology (such as IQ, OQ, PQ), able to independently develop validation plans, analyze data, and write reports;

5. Proficient in domestic and international medical device regulations (such as Chinese GMP, FDA, ISO13485, MDR, etc.), able to accurately translate regulatory requirements into validation standards.