Gaurav Gandhi

Gaurav Gandhi, Manufacturing Specialist  

"It gives me the utmost satisfaction to bring my experience to help Wisconsin companies become world-class manufacturers.  In today’s fast changing economy and technology, it is imperative that Wisconsin manufacturers take advantage of proven methodologies that have made companies successful.  The first step to that is to have a well-established quality management system.  It not only brings structure to the organization and the business, but successful companies use a smart quality management system to streamline their processes and promote a culture of continuous improvement, which makes their business competitive and attractive."

920.588.7348  Email

Gaurav brings to WMEP almost 20 years of manufacturing experience of which over 15 years are in Quality.  His manufacturing experience reaches from textile industry to medical devices, from automotive and metal machining to pharmaceuticals. His latest experience comes from the medical device industry in San Francisco, CA in Quality and Regulatory where he helped start-up companies get ISO 13485 certified, pass FDA inspections, and get CE mark (market clearance for commercialization) in the EU.  Over the years, he has helped small and large manufacturers stay compliant with ISO standards and other regulatory agencies such as Food and Drug Administration (FDA).  He has led several Six Sigma and Continuous Improvement projects at these companies to improve their quality standards and make them more profitable.

Skill Set:
Industries – Medical Devices, Bio-technology, Pharmaceutical, Automotive, Metal Machining, Textiles

• ISO 13485, ISO 9001, TS 16949, PPAP, APQP, 21 CFR 820 QSR, 21 CFR 210/211, ICH Q8/Q9/Q10
• Six Sigma Black Belt project implementation (DMAIC process)
• Statistical Process Controls, Design of Experiments, Taguchi Methods
• Malcolm Baldrige Award application process
• Cost of Quality, Quality Tools including Problem Solving (PDCA Cycle)
• Software Validation regulations, Electronics records and Signatures requirements
• Risk Management including FMEA, HACCP
• Geometric Dimensioning and Tolerancing
• Pro-Engineer, CAD/CAM , CNC machining

Experience:

• Director of Quality and Regulatory – Served as Management Representative for several companies
• Quality Systems Manager
• Six Sigma Black Belt
• SPC Coordinator
• Safety Officer

Education and Certification:
Gaurav holds a BS degree in Machine Tool Design and an MS degree in Industrial and Manufacturing Engineering degree with specialization in CAD/CAM and Quality. He has acquired several certifications from his experiences including ASQ Certified Six Sigma Black Belt, ASQ Certified Quality Engineer and Certified Lead Internal Auditor.  He is a Senior member of American Society for Quality (ASQ), a member of Regulatory Affairs Professional Society (RAPS), Engineering Society of Detroit (ESD), and Association of Machine Tool Engineers (AMTES).