Senior Quality Engineer@ Innovize
Saint Paul, Minnesota, United States
Tom Quintavalle
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University of St. Thomas
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FlashIntel GPTTom Quintavalle is a highly experienced Senior Quality Engineer and Regulatory Affairs specialist with 44.5 years of work experience. He specializes in quality system, quality management, and medical devices. Currently, he works at Innovize, a contract manufacturer of medical devices and disposables, where he focuses on validating equipment, production, and test processes to ensure consistent manufacturing. Tom is skilled in developing and performing statistical tests to verify process outcomes. He also provides guidance and training to Innovize personnel regarding FDA regulations and maintains the product listing status on the FDA web site. Tom completed his Masters degree in Regulatory Science from the University of St. Thomas.
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About
Currently working at Innovize, a contract manufacturer of medical devices and medical disposables, as a Senior Quality Engineer and Regulatory Affairs specialist. My work primarily consists of validating equipment, production and test processes to insure new products are consistently manufactured to design specifications. I develop and perform the appropriate statistical tests to verify process outcomes. In addition, I will write procedures that are used to operate equipment and manufacture products.As a Regulatory Affairs Specialist, I provide guidance and training to Innovize personnel regarding FDA regulations as they apply to company operations and specific products. I also maintain the product listing status on the FDA web site. Completed my Masters degree in Regulatory Science from the University of St. Thomas in 2016. This Engineering program is designed specifically for the medical device industry.
...See MoreWork Experience
Senior Quality Engineer
Medical Equipment Manufacturing
Tom Quintavalle's Professional Milestones
- Quality Manager (1997-06-01~1999-12-01): Implemented advanced quality control processes, resulting in increased product quality and customer satisfaction.
- Quality Manager (1995-03-01~1996-12-01): Implementing a quality management system to ensure product excellence and customer satisfaction.
Education
Regulatory Science
2011-2015Skill
Quality System
Quality Management
Medical Devices
Iso 13485
Manufacturing
Fda
Regulatory Affairs
Operations Management
Project Management
Continuous Improvement
Business Process Improvement
Statistics
Technical Writing
Regulatory Submissions
Six Sigma
Process Improvement
Product Development
Certification
Colleagues
John Freedman
Vice President Of Sales And Marketing
Dave Jessen
Owner | Vice President - Sales & Marketing
Patrick Thielen
Chief Financial Officer | Chief Information Officer
Julie Cameron
chief executive officer at excel scientific inc
Jim Gaffney
vice president of customer operations at innovize inc
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Tom Quintavalle works for Innovize
Tom Quintavalle's role in Innovize is Senior Quality Engineer
Tom Quintavalle works in the industry of Medical Equipment Manufacturing
Tom Quintavalle's colleagues are John Freedman,Dave Jessen,Patrick Thielen
Tom Quintavalle's latest job experience is Senior Quality Engineer at Innovize
Tom Quintavalle's latest education in University of St. Thomas
