Manager of Quality Department (QA)

Job Responsibilities:
1. Responsible for quality supervision and on-site inspection during the production process to ensure that the production process meets the quality requirements.
2. Organize and participate in environmental monitoring and complete environmental monitoring records.
3. Review production records and on-site records.
4. Investigate abnormal situations and deviations in the production process, assist in handling and feedback.
File management:
1. Assist in the preparation, revision and upgrade of departmental program documents.
2. Responsible for the management of documents and archives, the formulation and upgrading of document management processes, including the receipt, preservation, borrowing, and destruction of documents, etc., to ensure the implementation of document management SOP.
3. Support the provision of documents for internal and external audits and the provision of customer information, and be responsible for the establishment and maintenance of the process for the company to provide documents to the outside world.
4. Participate in document management deviation/CAPA activities.
job requirements:
1. Bachelor degree or above, major in chemistry, pharmacy, biology, etc.
2. More than 3 years of QA work experience in the medical device industry, familiar with ISO13485 or GMP quality management system, and have on-site QA management experience.
3. Familiar with ISO9001, ISO13485, GMP document management process.