Dennis Hoffman

Background

About Dennis Hoffman

Highly experienced technical manager with extensive experience in site management, quality assurance, regulatory affairs, and training within medical device, biomedical, pharmaceutical, software, and consumer product industries. Strong people, facilitation, and training skills. Is particularly effective in challenging environments. Synergizes well with teams across all organizational levels and disciplines.* Thorough understanding of regulations and standards including FDA (QSR), ISO (9001:2008, 13485:2003, ISO 14971:2007), IEC 62304:2006, USDA and NY State Department of Agriculture compliance. Able to rapidly interpret and apply to real world scenarios.* Significant Management Representative experience directing QSR and ISO Quality Management Systems. Has directed audit programs and lead audits at local and international levels.* Directed the successful expansion of scope to dual ISO13485:2003/ISO 9001:2008 certification as well as ISO 9001;2015/ISO 13485:2016 upgrades for a major Mil-Aero/Med Device Company software Design Center.* Direct experience with 510(k) FDA submission preparation and has directed successful de novo 510(k) submission (#DEN130033).* Direct experience with major Quality Management System functions, CAPA, HACCP and SPC methods.* Deep involvement with product development process, production scale-up, traceability/B.O.M. documentation, and packaging component evaluation.* Excellent presentation skills. Creates and presents quality and regulatory training programs on ongoing basis. Has presented to global audiences.