Job duties:

• Generating Supplier Corrective Action Request, controlling supplier parts quality related product issues and Return Material Authorization
• Solving problem for critical supplier parts quality related product issues/returns and cooperating with Supplier Quality Management & Panel Quality Engineering, and production team
• Coordinating with all related stakeholders to conduct root cause analysis and provide responsible weekly update on open topics
• Liaising with supplier regarding Supplier Corrective Action (CAPA) implementation and re-occurrence prevention.
• Conduct new product introduction/transfer related supplier qualification activities, e.g. First Article Inspection and Approval, validating supplier data and document, etc.
• Aiding in historical supplier issue data analysis to address systemic quality issue with key suppliers, new supplier sourcing activities, Monthly Operational Review (MOR) for reporting of supplier related issue and MRB review of supplier issues NC stock disposition.
• Performing lead supplier audit (audit planning, execution, reporting and action closure/effectiveness validation)
• Conducting internal audit activities.

Requirement:

• Diploma/Degree in Science, technology, engineering (Mechanical, Electrical, Industrial, Chemical, Biomedical), and mathematics or related major
• 3 to 6 years working experience in supplier quality, manufacturing process quality role. (Experience in Medical Device-related ISOs, Quality and Compliance standards, and GMPs).
• Practical knowledge in 8D problem solving, Root Cause Analysis and Control plan (FMEA, MSA and GR&R a plus!)
• Ability to manage multiple and complex tasks in a fast paced and challenging environment.

Grayson Tan Lee Fong License No.: 02C3423 Personnel Registration No.: R1441412

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