Performance-driven Quality Assurance Executive with management, quality assurance, regulatory compliance, and manufacturing operations experience in the Medical Device industry. Demonstrated expertise in successfully managing regulatory inspections, quality systems and product quality levels. Respected, hands-on solution-oriented leader with the ability to analyze, evaluate and resolve complicated problems. Strong work ethic and experienced leader of global multi-site operations. Highly collaborative, business and results oriented individual, with clear interactions across functions, countries, sites, operations and businesses. Effective people leader and communicator at all levels. Strong, demonstrated, mentoring capability. Reputation for being a strong leader and mentor to achieve outstanding results.Specialties: Quality Assurance, Medical Device, 21 CFR 820 Quality System Regulations(QSR), Current Good Manufacturing Practice (cGMP), ISO 13485 ,MDSAP, Medical Device Directive (MDD) 93/42/EEC, EU MDR 2017/745, Risk Management (ISO 14971), CAPA, Canadian Regulations (CMDCAS), SOP's, Quality Manual and Quality Standards.
Listed skills include Fda, Quality System, Capa, Iso 13485, and 46 others.