Responsibilities:

• Report to the Quality Manager based in Hong Kong.
• Lead and support factory’s quality engineers to develop and improve the supplier selection and monitoring processes, it includes:
• Deploy quality requirements to suppliers to ensure the compliance of medical QMS (ISO 13485), regulatory (FDA/CE) and customer specific requirements.
• Conduct on-site assessment for selection of new potential supplier.
• Conduct supplier audit to evaluate the quality performance of critical suppliers.
• Drive supplier’s improvement to minimize the risk and impact from cost of supplier poor quality.
• Generate and maintain supplier performance metrics and reports.
• Lead and drive supplier to take effective corrective actions for non-conformance and customer complaints incidents.
• Assist NPD Engineer to define components/parts specification (during New Product & process Development phases) to ensure supplier process capability is effective.
• As technical guidance of supplier to develop control plan, sampling strategy and relevant process control to ensure supplier manufacture and deliver quality parts, materials and services per applicable industry standards, regulatory and customer requirements.
• Define receiving inspection requirements as required and associated test method validation.

Requirements:

• Bachelor Degree in Engineering, Science or Technical field.
• 8 years+ working experience in Quality, Engineering or related technical functions
• 5 years+ working experience on supplier quality management and/or factory audit.
• Familiar with quality management systems (ISO 13485, CGMP), process control, statistical techniques and common quality tools such as CAPA, 8D, FMEA, MSA, SPC…etc.
• Strong technical knowhow on silicon rubber, plastics, metals, molding and corresponding control and testing criteria/tools/standards.  
• Experience in higher quality standards industry/criteria such as automotive, medical, pharmaceutical or good laboratory practice would be a plus.
• Willing to travel in China for supplier quality audit or supporting factory operation around 2 weeks per month.
• Good command of spoken and written English and Chinese (Cantonese and Mandarin)