- Responsible for quality assurance, monitoring, and coordination and tracking of design and development defects in the design and development process, and driving quality improvement in the R&D process;
- Supervises product compliance in the design and development process throughout the full life-cycle;
- Participates in the design review, design verification and design confirmation process of new products, and assists in data collection, reduction, statistics and analysis in the product R&D process;
- Establishes, maintains and continuously improves the quality management system (in the design and development module), and ensures its compliance with regulatory requirements;
- Formulates and improves the incoming, process, finished goods and outgoing inspection procedures (including standard samples and boundary samples when necessary);
- Identifies product performance requirements and establishes new test methods, and introduces measuring equipment;
- Assists in the R&D risk management activities.
- Has specialized knowledge in the design and development system of medical device industry, familiar with risk management activities;
- Has experience in introducing medical device suppliers, familiar with regulatory requirements on supplier management;
- Understands relatively complex mechanical drawings, capable of using quality tools.
- Work experience in the medical device, electronics and automobile industries preferred;
- A certificate of ISO13485 Internal Auditor preferred;
- Good communication, organization, coordination and adaptation skills, and excellent stability preferred.