Responsibilities:

#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.

Requirements:

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.

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