QE Engineer II

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• , Responsible for organizing the quality management related to the production running and organizing the development of on-site quality management methods and strategies.
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Organize or participate in the disposal of non-conformance on site, including discovery, investigation, cause analysis, rectification measures and product disposal.

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Responsible for the transfer of related activities of the product or process development department, including the transfer or generation of quality standards, testing methods, online quality control plans and relevant documents.

Participate in production related change evaluation and corresponding follow-up action confirmation.

• FAI

Responsible for the FAI related and in-coming Inspection Job.

Participate the corresponding investigation and handling of post-market feedback (such as complaints).

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According to the requirements of the quality management system, if necessary, participate in the training of relevant staff.

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Participated in quality risk management, Handle risk activities related to process and product quality, such as process risk analysis.

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Participate in or (organize and cope with) audit according to quality system and regulatory requirements (such as internal audit).

Perform other tasks assigned by superior.

• Education Background:
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• At least bachelor degree in Electrical or Mechanical Engineering related background
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• Work Experience:
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• 5/.
• 5+ years' quality control working experience in electrical industry or active medical device industry.
• Be familiar with production and process quality control of active medical device manufacturer.

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