about 1 month ago
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.
Responsible for suppliers evaluation, selection, development and performance monitoring. Resolve material quality issues with suppliers.
Lead the quality assurance processes at incoming material, manufacturing processes and outgoing final products.
Manage quality assurance at product development stage to ensure the compliance to JMT QMS, customer and regulatory requirements.
Guide the product development process and associated verification and validation activities.
Lead the process and quality improvement (FPY) activities.
Managing and maintaining controls and documentation relating to QMS.
Lead all internal and customer audits, registrar and regulatory audits; address non compliance issues from both internal and external audits.
Maintain high standard of customer service to include investigation and resolution of quality complaints.
Measuring Key Performance Indicators. This includes defining, measuring, analyzing KPIs, used in product and process improvement.
Manage JMT hazardous substance free program (RoHS & WEEE).
Manage JMT risk management program and risk mitigation activities.
Degree or above in Engineering or related disciplines wiht 10 years or above related experience
Strong in QMS establishment and maintenance in ISO13485 and FDA QSA 820.
Solid knowledge on Medical device product development
Strong understanding on Risk management for medical device (ISO 14971); Knowledge in Gemba Kaizen in medical device production preferred
Supplier quality management in medical device industry is preferred.
Work location: Shenzhen