Founder and CEO, Quality Solutions and Support, LLC
Stephen Inglese is a Founder and CEO of Quality Solutions and Support, LLC. Mr. Inglese began his Quality Systems career with Florida Power and Light (FPL) Company in South Florida. During his career with FPL, he was instrumental in being awarded the prestigious Quality – Deming Award, the first United States firm to challenge then win the award once only achieved by a firm located in Japan.
During that time, Mr. Inglese was placed in a position as a facilitator and was given the opportunity to study under the direction of Japanese Union of Electrical Scientists, then teaching those within various locations of FPL under the Quality Improvement Program. During his time with FPL, Mr. Inglese was also serving in the United States Air Force Reserve. There, as a flyer in a Combat Search and Rescue Unit, he was given the opportunity to assist in the dissemination of the Total Quality Management program to a group of 500 Airman. This quality program provided the tools and techniques to achieve a successful quality improvement process. He continued his quality carrier with the Tribune Company in South Florida as a system analyst in providing data to assist in improving circulation of the firm’s local newspaper.
Mr. Inglese then transitioned to ISO 13485 and the medical device industry. He successfully maintained the ISO / FDA quality system for several medical device manufactures in the medical laser industry. During this opportunity, he created design history files for new devices and technical files to assist in marketing the devices within the United States and off shore. He led the firm through successful implementation of the Quality System as required by FDA and foreign notified bodies, internal and supplier audits and management reviews.
Mr. Inglese founded Quality Solutions and Support, LLC in 2010 to assist firms in maintaining (or developing) their Quality System be it ISO, FDA or Medical Device Directives, Health Canada or other Notified Bodies globally. This includes establishment and maintenance of these firm’s design controls, audits (internal or vendor), technical files and 510(k)s.
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