Responsible for the establishment and maintenance of the medical device QMS and EHS (Environment, Health, and Safety) systems, ensuring that applicable regulations and standards are incorporated into the company's procedural documents, promoting implementation, and participating in continuous improvement
Create a quality culture atmosphere, provide full lifecycle QMS and EHS process supervision, and enhance employees quality awareness
Responsible for Regulatory Affairs (RA) such as country approval registration (e.g., MDA, CE, FDA) and post-market surveillance of medical device products
As OSH-C, responsible for environmental impact assessment of the company's factory buildings, radiation protective shielding rooms, etc., identification of occupational danger factors, control, and declaration, etc.
Organize and follow up internal and external audit activities, conduct Data Analysis and early warning, monitor and report quality data, and support the implementation of management reviews
Interface with relevant affairs of the medical device regulatory department and environmental management department
Competencies:
Familiar with knowledge of quality management systems and medical device regulatory standards, including but not limited to ISO9001, ISO13485, QSR820, QMSR, MDR, ISO14971, ISO45001, and ISO14001, etc.
Familiar with medical device MDA, CE, and FDA registration knowledge, with experience preferred
Has experience in QMS and EHS quality audits
Experience in SHO (Safety & Health Officer)/OSH (Safety & Health Coordinator) is preferred
Work with earnestness, meticulousness, initiative, strong sense of responsibility, and excellent communication and coordination skills
Education Requirement:
Have at least a bachelor's degree
More than 3 years of work experience in medical device quality management system/EHS/RA related fields
