Job Brief
The Quality Manager is responsible for establishing, implementing, and continuously improving the company's quality management system. This role leads the quality team, oversees quality performance across the entire product lifecycle, and ensures compliance with regulatory and customer requirements. The Quality Manager works closely with cross-functional teams to resolve quality issues, drive corrective and preventive actions, and support continuous improvement initiatives.
Duties And Responsibilities
- Develop, decompose, and implement departmental quality objectives; supervise and evaluate the performance and daily work of subordinate quality engineers.
- Monitor work progress through regular meetings and report reviews; assign tasks and provide technical guidance and support to team members.
- Organize and deliver departmental training programs to enhance quality awareness, professional competence, and compliance knowledge within the team.
- Coordinate and manage quality performance across the full process, including incoming materials, manufacturing processes, product shipment, and customer complaints; regularly review key quality data, reports, and trends.
- Chair daily and periodic quality meetings; promote cross-functional collaboration with production, engineering, and other departments to resolve quality issues.
- Track and drive the implementation of corrective and preventive actions (CAPA), ensuring effective closure and continuous improvement.
- Lead the handling of customer complaints and major internal quality incidents; coordinate internal resources for rapid response, containment, and resolution.
- Supervise and follow up with responsible departments to conduct root cause analysis of significant quality issues, implement improvement actions, and verify effectiveness.
- Act as the primary liaison with the headquarters quality department; accurately report local quality status and support needs and promote the localization and execution of headquarters quality strategies.
- Coordinate with internal departments such as production and engineering to resolve quality disputes and eliminate bottlenecks in quality management processes.
- Perform other tasks and responsibilities as assigned by management.
Qualifications And Requirements
- Bachelor's degree or above in Quality Engineering, Biotechnology, or other related disciplines.
- Strong knowledge of and hands-on experience with the ISO 13485 medical device quality management system.
- Proven practical experience in quality management, preferably in a regulated manufacturing environment.
- Excellent communication, coordination, and team management skills, with the ability to work effectively across functions.
