職位描述
Principal Duties and Responsibilities:
?Support Senior QA manager to establish, maintain and improve quality management system basing on ISO13485 and local medical device regulation
?In charge of documentation control, change control, corrective and preventative and quality related training
?Coordinate the internal/external audit
?Maintain the CFDA related website database, such as annual report, traceability database and etc.
?Support manager for department KPI collection and monitoring and SER report.
?To assist and support other related duties for QA Dept.
Expected Areas of Competence (i.e. KSAs) :
Good communication skill with Strong logic thinking.
Strong Execution and problem solving capability.
Good teamwork and actively attitude. Actively participating as a team member to approach and completion of goals.
Effectively managing one`s time and resources to ensure that work is completed efficiently.
