1. Responsible for the design control of research and development projects, ensuring that project delivery meets the company's quality system requirements, and organizing reviews according to project milestones;
2. Participate in product development for each project, promote and implement product development process specifications to the product development team, and guide implementation;
3. Quality assurance and supervision during the project implementation process, based on the actual development stage of the project, supervise the project team to arrange design review, verification and confirmation, participate in design review, verification and confirmation. Ensure that every stage of the new product is supported by system control;
4. Urge the timely output of design materials that match the stage, review all materials output by the project team, and ensure the quality of document output;
5. Collect and provide feedback on problems (or non conformities) and improvement suggestions during the product development process, promote relevant responsible persons to conduct cause analysis and corrective and preventive measures, and track and verify corrective and preventive measures;
6. Be responsible for the optimization of the company's Product lifecycle related procedure documents;
7. Emergency handling and other tasks assigned by superiors.
1. Bachelor's degree or above, major in science and engineering;
2. At least 5 years of experience in the design and control of Class II or III sterile products;
3. Familiar with the GMP/ISO13485 quality management system and the management of new product development processes;
4. Serious and meticulous in work, with a high sense of responsibility, full of team spirit, service awareness, and strong persuasive, educational, and organizational skills;
5. Received training in design control.