PQMS Manager

About the role

The PQMS Manager leads the Quality Management System (QMS) team, ensuring day‑to‑day operations meet company policies and regulatory requirements. The role also serves as the NMPA Management Representative, overseeing compliance, product recalls, and post‑marketing surveillance for medical devices.

Key responsibilities

• Supervise daily QMS team activities, ensuring efficient execution of quality processes.
• Deploy and maintain QMS processes such as document control, training, and internal audits.
• Monitor QMS effectiveness through performance metrics, trend analysis, and action plans.
• Prepare for and support external audits, providing documentation and responses to findings.
• Manage non‑conformance reports, ensuring systematic tracking and preventive actions.
• Conduct risk assessments and drive risk mitigation strategies.
• Lead continuous improvement initiatives within the QMS.
• Oversee NMPA compliance, product recall activities, and post‑marketing surveillance.

Required profile

• Bachelor's or Master's degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
• Minimum 5 years of experience in Quality Management Systems, medical device regulatory affairs, or similar highly regulated environments.
• Preferred experience as a Management Representative for medical devices.
• Preferred certification: NMPA Management Representative certificate.

Required skills

• Regulatory Requirements
• Quality Management Systems (QMS)
• Project Management
• Data Analysis & Interpretation
• Process Improvements
• Technical Writing
• Budget Management
• Agile Methodology
• Training Content Development
• Regulatory Compliance