Description
Summary Highly reliable self-starter who can be counted on to complete assignments with little or no supervision. Motivated to learn and take on increasing levels of responsibility. Works well in high stress and fast-paced environments. A team player with exceptional interpersonal and communication skills a natural leader. Focused interests include CAPA management, document control maintenance, internal and external audits, calibration control activities, interfacing with customers and suppliers, computer software and problem solving. Significant Accomplishments * ISO 9001:2000 (with Medical Device ISO 13485:2003 focus) Lead Auditor * Successfully managed three departments (QA, Purchasing & Logistics) resulting in restructuring and improving the efficiency of the work flow while being responsible for over $20 million worth of inventory * Managed two FDA audits successfully with only two minor non-conformances * Managed one certification ISO 13485:2003 and CMDCAS audit and four re-certification audits * Reduced repair backlog of over 200 motors from 28 days to a 4 day turn-around in less than 2 months by streamlining production and improving workflow design * Received Class II and III Device licenses for 8 product lines from Health Canada Accomplishments * ISO 9001:2000 (with Medical Device ISO 13485:2003 focus) Lead Auditor * Successfully managed three departments (QA, Purchasing & Logistics) resulting in restructuring and improving the efficiency of the work flow while being responsible for over $20 million worth of inventory * Managed two FDA audits successfully with only two minor non-conformances * Managed one certification ISO 13485:2003 and CMDCAS audit and four re-certification audits * Reduced repair backlog of over 200 motors from 28 days to a 4 day turn-around in less than 2 months by streamlining production and improving workflow design * Received Class II and III Device licenses for 8 product lines from Health Canada
Accomplishments
Highlights:
Keywords
