Quality Engineer

l Assist the management representative in establishing, controlling, and effectively operating the quality management system documentation;

Plan, organize, coordinate, and review the measurement, analysis, and improvement of processes and products, and promote system improvement;

Lead internal audits of the quality management system;

Develop inspection operation documents, maintain relevant quality records, and identify inspection and status;

Organize the review and disposition of non-conforming products and check their control status;

Collect, summarize, classify, analyze, and process quality information. Monitor quality status, identify issues, and organize relevant departments to take corrective and preventive actions, and verify implementation effectiveness;

Assist the supply chain in auditing suppliers;

Handle customer feedback, adverse event monitoring, annual self-inspection of the quality management system, analysis, and improvement, and act as the complaint representative;

Coordinate with the HR department to conduct employee training on regulations and quality, assist in job training and competency evaluation for various positions;

Approve or reject the use of all materials and intermediate products, and release finished products for shipment. Evaluate and reward or penalize quality specialists.

Job Requirements Associate degree or higher, with good English reading and writing skills;

Preferably with more than three years of experience in quality management in pharmaceutical, food, or medical device manufacturing companies;

Familiar with process management and quality management of new projects, capable of making correct judgments and handling actual issues in the operation of the quality management system and product realization process;

Preferably familiar with relevant laws, regulations, and standards related to medical devices, as well as production processes, inspection specifications, and related standards for medical device products;

Strong document writing and internal audit skills;

Strong sense of responsibility, good communication skills, and team cooperation ability.

Operating company:Ormco

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