職位描述
歡迎機械專業應屆畢業生投遞本崗位！
職位職責 (簡要說明)
1.Ensures that the local Quality Management System meets current regulatory requirements and comply with local business operation;
2. Lead Development and/or Improvement of Quality system;
3. Improve and optimize the corrective action and preventive action system.
主要工作內容/職責（列舉清單）
1.Ensures that the local Quality Management System meets current regulatory requirements and comply with local business operation;
2. Ensures Cooperate policies are implemented within local SOPs within the local QMS as appropriate
3. Assist with development and/or Improvement of Quality System procedures and processes;
4. Assist with internal and supplier audit development, implementation, and execution;
5.Provide support to internal functions in the application, maintenance and improvement of medical quality systems and department specific processes;
6. Improve and optimize the corrective action and preventive action system for medical projects to ensure the compliance of FDA QSR820, ISO 13485:2003, etc.;
7.Responsible for managing 3rd party audit, regulatory compliance agency inspection;
8. Document control management for medical project;
9. Other tasks assigned.
任職資格
知識/教育程度
1. Bachelor’s Degree in Engineering, Science, or health-related field
2. Familiar with Quality system Improvement tools, such as 8D, fish bone, 5why，etc.
經驗/能力要求
1. 3-5 years related work experience in Quality Management system, at least two years’ experience as quality system engineer or above.
2. Quality Systems development, implementation, and training experience
3. Experience with ISO 9001, TS 16949 system requirements and training, ISO 13485 is preferred.
4. Must be able to work independently and have ability to work with cross-functional teams
5. Extensive project management skills with the ability to work under tight timelines and able to multi-task
6.Must have an understanding of fundamental quality system processes for design, CAPA and manufacturing in a regulated industry.
7. Familiar with MS-OFFICE;
8.Good communication and team work;
9. Fluency in oral and written English.
