- Quality Assurance & Systems: Maintain and improve the company's QMS in compliance with industry standards (e.g., ISO 9001 / ISO 13485).
- Root Cause & CAPA: Lead structured problem-solving investigations (using 5 Whys, Fishbone diagrams, and FMEA) to resolve product defects and customer complaints; implement Corrective and Preventive Actions (CAPA).
- Process Control & Metrics: Develop, implement, and monitor Statistical Process Control (SPC) charts and define Acceptable Quality Limits (AQL) for manufacturing.
- Auditing: Conduct internal process audits and participate in external supplier or regulatory audits.
- Continuous Improvement: Identify bottlenecks, reduce waste, and improve production yields using Lean and Six Sigma methodologies.
- Documentation: Create and update quality metrics reports, inspection plans, and standard operating procedures (SOPs).