Strategic and execution-oriented Compliance and Quality Professional. Worked with Fortune 500 Companies in the Medical Device industry the last seventeen years in the areas of Commercial Quality, Regulatory Compliance, QMS and Complaint Handling and Investigation. I have in-depth knowledge of global regulations/guidelines, interpretation and application including 21 CFR 820, 205, 803,11, 210, 211, MDSAP, ISO 13485, 9001, MDD, EU MDR 2017/745 and ISO 14971/IEC 62366, IEC 62304 SDLC and ICH E-6.Experienced in QMS, Regulatory Compliance IA Program Management, Consulting, DI, New Program Process & Procedure and Work instruction development including CQ State BoP Licensure requirements, IA Program Development (Consultant), Data Integrity and Global Audit Risk Management in various locations including on-site, hybrid and remote.Over nine years of experience as a certified Lead Auditor, with increasing expertise responsibilities including IA planning, execution, report writing & distribution, metric reporting, RCA & CAPA initiation, and EA Inspection Readiness skills including Backroom Lead, Mock Inspection execution, Gap Assessment and Development of an EA Announced/Unannounced Audit Readiness Playbook and templates. I am experienced educating SMEs on robust RCA & CAPA effectiveness and monitoring, Non-Conformance management, Training and Curriculum Development, Supplier Quality Monitoring, Continuous Improvement and Gap Analysis. I am well versed with presenting to Stakeholders and management. I have excellent execution, problem solving and decision-making skills. I am comfortable working in matrix environments and collaborating with global teams across various time zones.I am also a Registered Nurse with an active license and experience in Health Care industries in the areas of Quality and Process Improvement, Best Practice Methodologies, UM, CM, Discharge Planning, Managed Care (hospitals & insurance companies), Revenue Cycle Management & Patient Care.
