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
