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Purpose:
61 Understand the product quality requirements and production quality system requirements, monitor the factory production process and product quality, to ensure that the products meet the registration standards and industry standards to ensure that the production process meets the requirements of regulations and quality management system requirements.

Your role:
61 Plan the relevant quality process during product realization according to the standards and regulations of different countries and markets, supervise the implementation the activities to ensure that the implementation is in accordance with the planning requirements, and ensure the compliance of regulations and quality system.
61 Establish incoming material inspection procedure, ensure relative inspection record are true, accurate, complete and traceable.
61 Familiar with ERP system (SAP) to establish and maintain the DMR, inspection plna, sampling scheme, etc. for each incoming material.
61 Based on nonconforming product disposition procedure, identify, segregate. Investigate and dispose of nonconforming products.
61 Organize and coordinate the investigation, analysis and improvement of quality issue form production or feedback from external and internal. To ensure the effective implementation of corrective and preventive actions to ensure the quality compliance of products.
61 Monitor the relevant quality objectives, support and drive the achievement of the relevant quality objectives.
61 Execute product changes and process changes, to make sure the incoming inspection plan changes accordingly.
61 Establish and execute incoming material inspection method verification and validation procedure to ensure effective execution of inspection according to inspection procedures.
61 Support quality system compliance audit and product audit
61 Provide relative training for material quality personnel to ensure that they are trained and master relevant theoretical knowledge and practical skills.

You're the right fit if:
61 Education: Bachelor’s degree in engineer science or other equivalent experience.
61 Experience： Minimum 5 years of manufacturing quality experience; Well versed in Quality Engineering and Continuous Improvement techniques.
61 Competency and Skills：
61 Familiar with ISO 9001, ISO 13485 etc. QMS standards.
61 Familiar with China GMP relevant, CFR21 part 820, EU MDR etc. regulations.
61 Familiar with different process flow and process quality control, such as assembly, PCBA, soldering, injection molding, CNC etc.,
61 Proficient in statistical techniques and quality management tools, familiar with 6-sigma knowledge.
61 Strong organization, management, communication and coordination skills.
61 Well Knowledge with quality systems, quality tools, including Critical to Quality, FMEA, Root Cause Analysis, Pareto, 8-D, 5 Why, Audit skill, skills, or willingness to learn; experience with auditing suppliers preferred