Tom Bregani – Quality Systems Consultant (ISO 9001 & ISO 13485)

Tom Bregani is an accomplished quality professional with extensive background in quality assurance, operations, new product development, project management, and regulatory affairs. He has held positions of quality engineer, manager, and director. Tom is recognized for his ability to develop and establish proactive, interrelated business processes that ensure critical operational decisions are made at the front end of a business opportunity.

Tom’s quality engineering and management experiences span more than 30 years at technical companies. He has implemented Quality Management Systems in organizations that provide components, finished products, design engineering consulting services, and contract manufacturing services. He has worked with commercial, military, consumer, and medical device products, as well as automated assembly equipment. Tom is knowledgeable of ISO 9001, ISO 13485, ISO 14971, and the FDA Quality System Regulation (21 CFR Part 820). Other areas of expertise include supplier quality management, new product introduction, design verification, project management, lean tools, business process design, and process validation.

Tom Bregani holds a B.S. from Boston College in a physical science and an MBA from Franklin Pierce University. He is a trained Quality Auditor. Tom has been an ASQ Certified Quality Engineer for over 30 years. He has held various Leadership positions in his local chapter of ASQ.

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