Gaurav Gandhi

Owner of SG Consulting

Phone: 920-252-5300

Email: gauravgandhi@sgconsultingllc.org

Gaurav has 30 years of experience in manufacturing and consulting services for the medical device, automotive, metal foundry, paper industry, semiconductor, software, printing and general manufacturing industries. with quality management systems and continuous improvement. Gaurav helps clients improve quality and performance to attain operational excellence.

SKILLS:

• Quality Management System deployment
• Continuous Improvement
• Medical device regulations 
• Regulatory strategy for medical devices (CE Marking, 510(k))
• Problem-solving methodologies
• Lean Sigma implementation
• Kaizen and OEE improvements
• Process Validation, Software Validation for medical devices

EXPERIENCE:

• 25+ years in Quality and Regulatory with multiple industries
• 100% success at 3rd party audits for 50 + quality system implementations 
• Auditing experience of over 750 “audit days”
• $750 MM in savings/growth Lean Six Sigma project/mentoring/training from over 1,00 projects mentored and 50 projects completed
• Over 1,000 training sessions conducted, including public classes, and as Adjunct Professor
• Unique ability to develop a quality system that blends with continuous improvement

TRAINING

• Known to keep trained engaged throughout the training
• Trained and developed personnel in ISO standards and  Lead Auditor
• Conducted Yellow Belt, Green Belt and Black Belt training for individual clients and public sessions
• Conducted training seminars on PPAP, 8D, Problem-solving

CERTIFICATIONS

• Lead Auditor for ISO 9001, ISO 13485, IATF 16949, AS 9100D, ISO 14001, ISO 45001 management quality systems
• Six Sigma Black Belt
• Root Cause Analysis
• Process Validation
• Software Validation
• Supplier Management

EDUCATION:

• Northwestern University - Kellogg School of Management: Executive MBA
• Wayne State University: Master of Science, Industrial and Manufacturing Engineering

“It gives me immense pleasure and great satisfaction to hear from my clients what they have accomplished. Be it another successful year of high impact cost improvement projects, finally seeing the quality system actually helping us solve problems, or getting market clearance for our medical device, all the reasons why I love what I do, help my clients be more successful!”