- Shanghai, China
- Full-time · Associate
- 5+ years
Responsible for day‑to‑day operation, maintenance, and improvement of the medical device quality management system (QMS) and quality management of distribution activities, ensuring compliance with Chinese medical device regulations and ISO 13485.
Responsibilities
- Manage implementation and maintenance of the QMS in accordance with ISO 13485 and applicable regulatory requirements.
- Oversee document and record control, change control, quality training, and CAPA.
- Plan and conduct internal audits and supplier audits, ensuring findings are investigated and closed.
- Coordinate assessment and disposition of nonconforming products and quality deviations.
- Oversee quality operations across distribution, including supplier qualification and outsourced storage and transportation.
Requirements
- Bachelor’s degree or higher in medical devices, biomedical engineering, electronic engineering, automation, mechanical engineering, software engineering, medicine, pharmacy, bioengineering, quality management, or a related discipline.
- Nice to have: software quality management
- Nice to have: MAH management
- Nice to have: ISO 13485 internal auditor certification