CNY30,000- CNY 50,000
9 days ago
#1 Implement and maintain a Quality Management System, in conformance with FDA 21CFR820 and ISO 13485:2016, through the integration of internal and external/medical device industry best practices. Appointed as QMS management representative of Johnson Medtech.
#2 Responsible for suppliers evaluation, selection, development and performance monitoring. Resolve material quality issues with suppliers.
#3 Lead the quality assurance processes at incoming material, manufacturing processes and outgoing final products.
#4 Manage quality assurance at product development stage to ensure the compliance to JMT QMS, customer and regulatory requirements.
#4 Guide the product development process and associated verification and validation activities.
#5 Lead the process and quality improvement (FPY) activities.
#6 Managing and maintaining controls and documentation relating to QMS.
#7 Lead all internal and customer audits, registrar and regulatory audits; address non compliance issues from both internal and external audits.
#8 Maintain high standard of customer service to include investigation and resolution of quality complaints.
#9 Measuring Key Performance Indicators. This includes defining, measuring, analyzing KPIs,
used in product and process improvement.
#10 Manage JMT hazardous substance free program (RoHS & WEEE).
#11 Manage JMT risk management program and risk mitigation activities.
1 Degree or above in Engineering or related disciplines wiht 10 years or above related experience
2 Strong in QMS establishment and maintenance in ISO13485 and FDA QSA 820.
3 Solid knowledge on Medical device product development
4 Strong understanding on Risk management for medical device (ISO 14971); Knowledge in Gemba Kaizen in medical device production preferred
5 Supplier quality management in medical device industry is preferred.
6 Work location: Shenzhen.