Quality engineer II

主è¦èè´£ Core Job Responsibilities

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• Master Consumable Control, Validation and CAPA (Corrective Action and

Preventive Action)

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• Knowledge to use Quality Operations tools including M-files, and TrackWise to maintain quality system
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• Promote the Quality Tools (FMEA, SPC, DOE and etc.), to improve process, equipment and product quality
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• Knowledge on the manufacturing process
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• Equipped with basic engineering knowledge including:
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Metalic material application (including stainless steel, iron etc.)

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Basic knowledge of lubricant

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Application of rubbery gasket

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Piping and equipment installation and commissioning acceptance

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Mechanical drive structure and theory (including gear wheel, chain wheel and strap drive etc.)

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• Knowledge of manufacturing automation control
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• Knowledge of plant material and finished good management
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• Able to discover problem in daily work and resolve the issue accordingly
• ææRCA（6Måå åæ）å5WHYå·¥å·，è½å¯¹äºä»¶åå è¿èåæ
• Master of RCA (Root Cause Analysis â 6M) and 5 WHY tools, and use the tools to analyze and identify root cause
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• As representative of quality department involve in event investigation and root cause analysis
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• Able to identify critical point, analyze and improvement opportunity for manufacturing equipment and process
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• Communicate with Abbott Division and Regional SME on ANJX event for assessment in order to resolve the event
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• Handle associated documentation for Consumable Control, Validation, Customer Complaint and CAPA
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• Handle routine documentation, ensure compliance with GDP (Good Documentation Practice) and archive the document in repository
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• Be able to write quality investigation report.
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• Ability to review report and provide comment
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• Prepare and revise SOP (Standard Operating Procedure) related to Consumable Control, Validation and CAPA (Corrective Action and Preventive Action)
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• Ability to perform training to ANJX colleagues related to Consumable Control, Validation and CAPA (Corrective Action and Preventive Action)
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• Able to have an effective communication with different function department to develop a protocol for an event resolution. Follow up the protocol and track on the progress. Analyze result with conclusion
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• Other task assigned by superior

æä½å­¦åè¦æ±Minimum Education

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• Bachelor degree or above in Food and Pharmaceutical related discipline

æä½ç»éª/å¹è®­è¦æ±Minimum Experience / Training Required

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• 2 years working experience in food/pharmaceutical industry
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• Good practical knowledge of GMP and GDP in food/pharmaceutical manufacturing
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• Good knowledge and practice in documentation management
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• Knowledge of HACCP and ISO systems would be preferred
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• working exposure and understanding of manufacturing process
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• Relevant experience or equivalent combination of education and work experience
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• Team player with collaboration capability and good communication skills
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• Familiar with infant formula dairy product regulation, and knowledge of the role and responsibility

definition by regulation would be preferred

• ææè´¨éè¿è¥å·¥å·åæ¬M-files, GQMS and Trackwise
• Knowledge to use Quality Operations tools including M-files, GQMS and Trackwise
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• Able to read, write, listen and speak in English and Mandarin