Establish & Maintain QMS: Develop, implement, and upgrade the Quality Management System (QMS) in alignment with international standards (such as ISO 9001, IATF 16949 for automotive, or ISO 13485 for medical devices, depending on the industry).
✓Audit Readiness: Lead internal and external quality audits, serve as the primary point of contact for regulatory bodies, and ensure swift closure of any non-compliance findings.
✓Standard Operating Procedures (SOPs): Review, approve, and enforce SOPs across the receiving, in-process, and final inspection stages.
2. Operations & Control
✓Defect Prevention: Implement advanced quality tools like FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), and MSA (Measurement Systems Analysis) to predict and prevent defects.
✓Root Cause Analysis: Lead complex investigations into product failures or customer complaints using 8D, 5-Why, and Fishbone (Ishikawa) methodologies to implement permanent corrective actions (CAPA).
✓Vendor Quality Management: Collaborate with the procurement team to evaluate supplier quality, establish incoming material standards, and conduct supplier audits.
3. Continuous Improvement & Metrics
✓KPI Tracking: Monitor and report on key quality metrics, including COPQ (Cost of Poor Quality), PPM (Parts Per Million) defect rates, FTR (First Time Right), and customer return rates.
✓Lean Practices: Drive continuous improvement initiatives using Lean Six Sigma methodologies to eliminate waste and optimize process efficiency.
4. Leadership & Team Management
✓Team Development: Lead, mentor, and build the capability of the quality engineering and inspection teams (QA/QC Engineers, Programmers, Inspectors).
✓Culture Shift: Foster a plant-wide Quality First mindset by training production operators and floor staff on quality standards.