Job Description

QUALITY IN PROCESS

• Monitor and analyze plant yield performance; identify trends, gaps, and opportunities for improvements
• Daily non-conformance management: Lead root cause analysis and corrective/preventive actions (RCA / CAPA) for product and process non-conformances
• Collaborate with cross-functional teams (Engineering, Operations, Production, and R&D) to implement effective quality solutions
• Apply statistical analysis tools (SPC, DOE, regression, hypothesis testing, etc.) to evaluate process and product data
• Support and maintain the Quality Management System (QMS) in compliance with industry standards (ISO/Medical, as applicable)
• Drive continuous improvement projects to enhance process capability, yield, and customer satisfaction
• Conduct line monthly audit with Manufacturing and Process
• Prepare and present reports, metrics, and findings to management and stakeholders

CONTINUOUS IMPROVEMENT

• When there are major defects, leverage the QRQC (Quick response quality control) / PDCA methodology to understand the root cause and initiate preventive actions
• Propose and drive Projects for productivity / process improvement / PPM improvement with cross-functional involvement

CUSTOMER SATISFACTION / EXTERNAL AUDIT

• Act as conduit between Customer Quality and Internal stakeholders. Investigate customer-reported issues, coordinate root cause analysis, and implement corrective actions using problem-solving tools
• Support supplier / customer quality in audits

Job Requirements

• Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial) or equivalent
• Minimum 2–3 years of experience in Quality Engineering or similar role within medical device or medical related industry