Quality assurance leader with extensive experience in med. device quality systems, design assurance, and manufacturing / supplier quality. Significant roles as technical staff and head of quality in numerous design, manufacturing, and contract manufacturing environments.Key Skills - - Quality Leadership / Management- Leadership success at two different startup medical device companies -> implementation of Quality Systems (GMP / EU / MDD / MDR / ISO 13485 medical devices).- Demonstrated abilities to effectively communicate verbally and in writing, and effectively influence diverse stakeholders, as well as make competent, risk-based product safety decisions based on the analysis of critical information. Able to balance analysis with decisiveness alongside business/regulatory risks.- Extensive background in regulatory agency and notified body audits (to include FDA). - BSI certified 13485 lead auditor- Skilled in Design Risk Management / Product Commercialization / Post Market Surveillance. - Super user / Implementation / experience - > Arena Product Life Cycle Management (Software) - Expert | MS SharePoint - Demonstrated abilities to design, develop, setup, and manage SharePoint web sites, libraries, lists, page layouts, apps, promoted links, permission sets, and other business applications that support business and quality management system workflow activities (Nonconformances, CAPA’s, Complaints, Equipment PM and Calibration, Training, Document Change Orders, Sales Order Processing, Lot Tracking, etc.).