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.
Consultant to domestic and foreign entities in the core arenas of quality, compliance, medical device, product review, regulation/requirement integration, and risk management.
Medical Device Consulting Projects:
ACTAMAX SURGICAL MATERIALS, LLC | Wilmington, DE 2012–2015
Director, Quality Management
50/50 joint venture between DuPont and DSM Biomedical.
E.I. DUPONT DE NEMOURS & CO., INC. | Wilmington, DE 2007–2015
Global Quality Manager – Industrial Biosciences Business Unit
Led product quality and quality management systems in the New Product Development arena. Simultaneously supported Actamax Surgical Materials, LLC joint venture.
HOLOGIC, INC. | Wilmington, DE 2002–2007
Plant Quality Assurance Manager
Guided/supported manufacturing organization’s FDA regulatory and ISO quality management systems for successful digital mammography detector assemblies production and release.
W.L. GORE & ASSOCIATES, INC. | Elkton, MD 2000–2002
Quality Assurance Associate
DADE BEHRING, INC. | Wilmington, DE 1980-2000
(formerly DuPont Medical Products, Diagnostics Division)
Quality Assurance Manager
QA & Compliance Manager
Product Quality Management Engineer
Production Supervisor
QA Supervisor
Process Engineer
Systems Support Engineer
Development Engineer