Richard Wynkoop
President & CEO at Vision28 | Redmond, Oregon, United States
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Richard Wynkoop, as President & CEO of Vision28, leverages his extensive background in quality management and regulatory affairs to drive the organization’s mission of providing pragmatic solutions for the FDA-regulated industry. With a career that spans various roles—from Quality Engineer to Director of Quality Assurance and Regulatory Affairs—Rich brings a wealth of expertise in navigating the complexities of compliance and quality systems within the medical device sector. His hands-on experience equips him with a unique perspective on the challenges faced by organizations striving to meet stringent regulatory requirements, such as ISO 13485:2016 and 21 CFR Part 11.
At Vision28, Rich leads key projects that focus on enhancing quality management systems and ensuring compliance with both U.S. and international regulations, including those set forth by European Notified Bodies and Health Canada. His strategic approach emphasizes cost-effective solutions that not only meet regulatory standards but also drive operational excellence. Rich’s proficiency in risk management methodologies, such as FMEA and ISO 14971, enables Vision28 to assist clients in identifying and mitigating potential risks associated with their products.
Under his leadership, Vision28 has positioned itself as a trusted partner for organizations navigating the complexities of regulatory submissions and quality assurance processes. Rich’s commitment to fostering a culture of continuous improvement and innovation is evident in the company’s tailored services, which range from comprehensive regulatory support to targeted consulting for specific compliance challenges. His vision for Vision28 is to empower clients to achieve successful outcomes while maintaining the highest standards of quality and safety in their products.
President & CEO at Vision28 in September 2016 to Present
Enjoying Greater Oregon at Medical Device Quality and Regulatory Professional in August 2015 to September 2016
Vice President, Regulatory Affairs, Quality Assurance at Medline Industries in April 2013 to August 2015
Director, Corporate Regulatory Affairs at Welch Allyn in January 2010 to April 2013
Director, Division Quality and Regulatory at Welch Allyn in October 2008 to January 2010
Sr. Manager, R&D QA at Welch Allyn in April 2004 to October 2008
Site Engineering Manager at Abbott Laboratories in January 2002 to January 2004
Plant QA Manager at Abbott Laboratories in June 1997 to December 2002
R&D Engineer, QA Engineer at Abbott Laboratories in August 1984 to May 1997
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Team Motivation
Communication
Quality Assurance
Manufacturing
FDA
ISO 13485
Medical Devices
Engineering
Design Control
R&D
Quality System
Validation
CAPA
ISO 14971
Cross-functional Team Leadership
Product Launch
Verification and Validation (V&V)
Product Development
Regulatory Affairs
Quality Control
GMP
Continuous Improvement
ISO Standards
Lean Manufacturing
21 CFR Part 11
Change Control
Biomedical Engineering
Biotechnology
Corrective and Preventive Action (CAPA)
CE marking
Capital Equipment
Automation
FDA GMP
FMEA
Hardware Diagnostics
ISO
Management
Market Development
Process Improvement
Quality Auditing
Quality Management
Regulatory Requirements
Regulatory Submissions
Research and Development (R&D)
Root Cause Analysis
Six Sigma
Sop
Strategy
Supplier Quality
V&V
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Discover more about Vision28What is Richard Wynkoop email address?
Email Richard Wynkoop at [email protected] and [email protected]. This email is the most updated Richard Wynkoop email found in 2026.
What is Richard Wynkoop phone number?
Richard Wynkoop phone number is +15416049654 and +15037509178.
How to contact Richard Wynkoop?
To contact Richard Wynkoop send an email to [email protected] or [email protected]. If you want to call Richard Wynkoop try calling on +15416049654 and +15037509178. (updated on November 04, 2024)
What company does Richard Wynkoop work for?
Richard Wynkoop works for Vision28
What is Richard Wynkoop's role at Vision28?
Richard Wynkoop is President & CEO
What industry does Richard Wynkoop work in?
Richard Wynkoop works in the Medical Equipment Manufacturing industry.
Richard Wynkoop Email Addresses
Richard Wynkoop Phone Numbers
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