Quality Partners and associates have MANY years of experience both in the U.S. Food and Drug Administration (FDA), and in the medical devices, pharmaceuticals and medical gas industries.
For example, our principal, Mr. Harold Jones, has 20 years of employment experience with FDA. He has served as a PMA reviewer in the Office of Compliance, and was a testing engineer at the Winchester Engineering and Analytical Center, Boston, MA. Mr. Jones has also been a Medical Device specialist, a District Engineer, and a Compliance Officer with the FDA.
Mr. Jones also has 16 years of experience in the class II/III medical device, pharmaceutical, and medical gas industries, specializing in FDA regulatory compliance, Good Manufacturing Practices auditing, quality system development, consulting, and training.
Mr. Jones brings vast experience managing global regulatory affairs departments in the medical technology and pharmaceutical arenas. He is deeply committed to team building and has a demonstrated track record leading growing companies, bringing complex products to market and operating on an international scale. Harold is ideally suited to help lead your company to the next level of success.
Mr. Jones’ education includes a B.S. in Electrical Engineering from the University of Washington, Seattle. Harold is also a graduate of the FDA Executive Development program and has completed executive management programs at George Washington University and the Center for Creative Leadership. Harold is a Lead Auditor with international experience including assignments in Canada, France, Germany, Switzerland, Japan, Ireland and many other countries.
QUALITY PARTNERS Consultants to: Medical Device | Pharmaceutical | Bioresearch Monitoring | Medical Gases & Other FDA Regulated Industries
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Harold was an analytical engineer for the FDA and has investigated, analyzed and diagnosed failure modes and effects for numerous medical devices. While the Small Business Office manager for FDA's Southwest Region, he assisted the smallest to the largest device manufacturers on a world-wide basis to become GMP compliant and pass FDA inspection. He has directed regulatory affairs and quality assurance efforts in companies such as Guidant-Intermedics and Air Liquide America.
Our associates are also ex-FDA specialists and industry experts having accumulated wisdom measured in decades!
This unique combination of industry and FDA experiences has provided Quality Partners with a unique grasp of the problems and solutions to the GMP problems encountered by the device and pharmaceutical manufacturers.
Quality Partners also has an advantage over larger established firms. We have no overhead for corporate office space or the burden of legions of support staff that other large consulting groups have. This means that we can offer LOWER costs to our clients. In fact, we are so sure that we have the best pricing available that we have published our costs. If you want to know what we charge, please use this hyperlink and we will send you our price list. Or simply e-mail us your address and we will send you an information package.
It is easy to see that Quality Partners has the skill, knowledge, and above all , the pricing to provide your company with an affordable and complete regulatory or compliance solution. So, whether you want to improve your quality system, provide FDA knowledge-based training, or you are faced with an FDA crisis, Quality Partners should be your first choice.
