Phaniendra Somraj

---

As a Lean Six Sigma Master Black Belt, I lead enterprise-wide transformation programs that drive measurable results through data-driven decision-making, operational excellence, and process innovation. My approach integrates Agile and Lean principles to accelerate outcomes and sustain cultural transformation within organizations, enhancing everything from process efficiency to customer satisfaction. 

Key Expertise:

• Strategic deployment of Lean Six Sigma programs
• Enterprise portfolio and benefits management
• Training design and certification governance through the Operational Excellence Academy

As a coach and mentor, I empower professionals to think critically, challenge the status quo, and create meaningful change through structured problem-solving. I’ve guided hundreds of emerging leaders, engineers, and executives to translate theory into real-world business value, helping them navigate challenges with creativity, confidence, and clarity. 

As a Certified ISO 13485:2016 Lead Auditor, I specialize in integrating quality management systems that adhere to international standards for safety, effectiveness, and compliance. My focus includes aligning design controls, risk management, and validation processes with business goals, ultimately fostering a culture of operational excellence. By incorporating Lean Six Sigma principles, my work ensures that companies not only pass audits but also build audit-ready cultures that thrive on continuous improvement.

Focus Areas:

• ISO 13485 QMS implementation and audit readiness
• Design controls, risk management, and CAPA systems
• Process validation (IQ/OQ/PQ) and documentation governance
• Supplier quality management and post-market surveillance
• Integration of Lean principles into regulatory environments through the Operational Excellence Academy