DSJ Global is partnering with a well-known multinational manufacturer of industry products and components that is currently looking for a Senior Quality Manager to head up the Quality Department for its new plant in Shenzhen.
The position is going to be based in Shenzhen and its main job duties are as follows:
- Leading the quality assurance processes from the incoming materials stage all the way through to the manufacturing process and final products.
- Devising an effective quality management system that conforms with FDA 21CFR820 and ISO 13485:2016 and implementing industry best practices.
- Leading the evaluation, selection, development and performance monitoring of suppliers.
- Managing quality assurance at the product development stage and ensuring compliance to customer and regulatory requirements.
- Leading quality improvement initiatives.
- Leading all internal and customer audits as well as regulatory audits.
The successful candidate will have the following credentials and experience:
- Experience in end-to-end quality management and product development within the medical devices space.
- Good understanding of risk management for medical devices (ISO 14971).
- Strong in maintaining quality management systems (ISO 13485 and FDA QSA 820).
- Degree or above in Engineering or related disciplines.
- Ideally 10+ years working in relevant positions.
Please apply with your detailed CV.