Ireland
Quality Systems and Compliance Consultant with over 20 years experience working in the Medical Device field. I am focused, enthusiastic, detail oriented and highly professional with any task or role I am given. Main areas of expertise - Risk Management - ISO13485:2016 - EU MDR - QMSR 820 and preparation for FDA Inspections - MDSAP
Focus on Quality and Compliance with demonstrated expertise in the following: ISO 13485:2016 QSR 820 Risk Management -ISO14971 Quality Audits Medical Device Single Audit Program (MDSAP) Services include Training, Mock Inspections, Gap Assessments Please contact me for further details
Trainer with AAMI for Quality Systems and Industry Practice, Design Controls and Risk Manangement
• Business lead in the Covidien and Medtronic Integration in the areas of Risk Management and Compliance. • Member of the Medtronic Risk Management Council • Business Process Owner for the Implementation of Covidien Audit and NCR Software on Agile. • Contributed in formulating and establishing Medtronic Corporate Policies and Procedures • Scheduling and leading Covidien Corporate Audits • Management of Senior Compliance Specialists and mentoring same to become lead auditors. • Ensuring site readiness for external audits such as FDA. • Communication with upper management on Compliance Issues. • Development of training certification programs for example: CAPA Investigator ceritfication • Defining group strategies and goals
• Served as Business Process Owner for the Implementation of Covidien Audit Software including Software validation. • Contributed in formulating and establishing Corporate Policies and Procedures • Scheduling and leading Corporate Audits for the International region. • Management of Senior Compliance Specialists and mentoring same to become lead auditors. • Ensuring site readiness before external audits such as FDA. • Communication with upper management on Compliance Issues. • Development of training programs for example: Risk Management, Internal Audit • Defining group strategies and goals
• Lead and participated in corporate audits of all Covidien International facilities • Developed, monitored and supported plants Audit Corrective Action Plans and ensured actions were appropriate and implemented in a timely manner to prevent recurrence • Developed and delivered compliance training programs, such as CAPA, Internal Auditor, Regualtion Training, Failure Investigation • Assisted with compliance remediation activities related to corporate and government agency audits