Senior Quality System Engineer
Senior Quality System Engineer
Posted on :
22-08-2025
Employer Active
1 Vacancy
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Job Description
Main Responsibilities and Authority
- Coordinate corporate & external quality system audit including ISO13485 MDSAP FDA QSR820 China GMP and Others like Costco GMP audit etc. and follow up the corrective actions and preventive actions for non-conforming
- Lead implementation of internal quality system audit and the follow up corrective and preventive activities.
- Daily maintain and improve the quality system monitor quality system implementation of each department and Cooperate with Global functions to ensure effective communication and implementation of Global QMS requirements related to local site.
- Collect maintain and understand related legal requirements of company QMS ensure the legal compliance of company QMS.
- Assist relative department for building the quality assurance process/system for the new or change process.
- Train newcomers occasionally about company level requirements of quality management system
- Company KPI data collection management and reporting
- Continuously contribute develop and implement ideas that improve performance.
- Other tasks assigned by the superior
Education
Bachelor or above in mechanical/electronic field preferred
Working Experience
- Above 5 years relevant working experience
- Good knowledge of ISO9001 ISO13485 and MDSAP and with the capability of planning QMS of medical device industry;
- Familiar with FDA QSR820 quality system and China GMP etc.
- Excellent English skill
Certificate
- ID certification of education. ISO9001 and ISO13485/MDSAP Internal audit certificate
Professional Requirement:
- Good coordination and communication skill
Other Requirement:
- High responsibility
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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