Rich Wynkoop is a seasoned executive who takes a pragmatic approach to quality management, regulatory affairs, and compliance to help clients achieve cost-effective and successful outcomes. His experience spans world-class enterprises and multinational organizations in medical device industries as a hands-on Quality Engineer, Research and Development Manager, Quality Assurance Plant Manager, and Director and Vice President of Quality Assurance and Research and Development.
This range of experience enables him to quickly target practical solutions to difficult problems. Rich has also spent significant time preparing for and hosting regulatory audits and remediating difficult audit observations. He has designed and implemented Design Control, Software Validation, CAPA, and other quality system elements that have stood up to robust examination by both Notified Bodies and FDA inspectors.
Rich has a BS in Electronics Engineering from Oregon State University, an MBA from Phoenix University, and was registered as a Professional Engineer in the state of Illinois. Rich was also a certified Zener Miller team facilitator and a certified DDI Leadership facilitator. Certified ISO 13485:2016 Lead Auditor, MDSAP Auditor, and EU MDR Auditor.