Quality. Compliance. Success
Helping medical device companies leverage the value of their quality efforts and reduce costs up to 20%, accelerate time to market by 25%, and control compliance risks leading to a reduction of audit findings by 33%.
Dedicated, well-organized, quality professional with expertise in quality engineering, assurance, control and management as well as product development and commercialization, post-market technical support, regulatory compliance and production management. Multi-faceted with experience in world-class medical device and biotech manufacturing operations.
Extensive background in vitro diagnostic medical devices, digital imaging equipment, neurostimulation devices, interventional devices, bio-based materials, and bio-polymer devices and delivery systems.
INNOVATIVE QUALITY CONSULTING, LLC, Wilmington, DE www.iQualityConsulting.com 2015 to current Owner, Principal Consultant
Medical Device Consulting Projects (2015 through present):
ACTAMAX SURGICAL MATERIALS, LLC, Wilmington, DE 2012 to 2015 (Actamax Surgical Materials, LLC, was a 50/50 joint venture between DuPont and DSM Biomedical) Director, Quality Management
Managed the creation, effective establishment and certification of the quality management system, enabling the successful development of an adhesion barrier medical device. Facilitated product development initiatives, including management of one clinical trial site.
E.I. DUPONT DE NEMOURS & CO., INC., Wilmington, DE 2007 to 2015 Global Quality Manager (Industrial Biosciences Business Unit)
Led product quality and quality management system efforts in the development of new products. Established business processes to facilitate the selection, qualification and support of critical contract manufacturing organizations (CMOs). Also supported the Actamax Surgical Materials, LLC joint venture.
HOLOGIC, INC., Wilmington, DE 2002 to 2007 Plant Quality Assurance Manager
Provided FDA regulatory and ISO quality management systems guidance and support to the manufacturing organization, ensuring effective production and release of digital mammography detector assemblies.
W.L. GORE & ASSOCIATES, INC., Elkton, MD
Quality Assurance Associate
Managed quality assurance activities for interventional devices under development.
DADE BEHRING, INC. (formerly DuPont Medical Products, Diagnostics Division), Wilmington, DE
Quality Assurance Manager
Managed multi-disciplined team effort to implement pilot phase of Product Data Management system. Demonstrated product development and manufacturing cycle time reduction feasibility and annual manufacturing cost reduction of over $100,000.
Previous roles include QA & Compliance Manager, Product Quality Management Engineer, Production Supervisor, QA Supervisor, Process, Systems Support and Development Engineer.