David McGrath
Vice President of Quality & Regulatory @Genalyte, Inc
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WORK HISTORY
Vice President of Quality & Regulatory @Genalyte, Inc
EDUCATION
University of Maryland
MS, Reliability Engineering
University of Maryland
Master of Science - MS, Reliability
San Diego State University
BSEE, Engineering
SKILLS
ABOUT DAVID MCGRATH
Experienced Leader of Global Quality and Regulatory Affairs with demonstrated successful leadership and proven results in the medical device and diagnostic industries. Strong quality assurance and regulatory compliance knowledge and skills compliment my technical engineering background. Experience gained in world class companies across industries is applied to deliver world class results, now specializing in Medical Device industry- Quality Management Systems (21 CFR 820, ISO 13485:2003,2012,2016)- EU Medical Device Regulation- Global Registrations: 510k, De Novo, EUA, CE, TGA, Canada MDR- New Product Development (Design Control) Quality and Regulatory Affairs- Supplier Approval, Monitoring, Surveillance and Control- Product Safety (IEC 60601-xx)- Global Cost of Poor Quality program- Risk management ISO 14971:2019- Certified Lead Auditor (ISO 13485, MDSAP)- MDSAP Single Audit Program- Product and Process Validation and Transfer- Reliability Engineering and Statistical Expertise- Global Compliance Leader (CAPA, Complaints, Vigilance, QMS)- Management Representative for FDA and International inspections- Certified Six Sigma Black Belt- Post Market Surveillance, Clinical Evaluation, Usability, and Technical Data for Medical Device
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