• Management Representative.• Implemented an auditable Quality System in both the US and Canada in less than one year.o Designed the Quality Manual.o Work closely with President to develop the Quality Policy while aligning Quality Objectives.o Developed the equipment calibration program and manage over 300 plus pieces of test equipment distributed in the field.o Establish all Quality System Procedures and Policies in accordance with 21 CFR 820 and Canadian Regulations.o Coordinate and conduct semi-annual and abbreviated Management Reviews.o Manage Corrective and Preventive Action Program.o Execute Quality System training company wide on an annual basis.• Received 2010 Business Award for establishing the Quality Management System.• Active member and representative in MITA (Medical Imaging & Technology Alliance) a division of the National Electrical Manufacturers Association.• Worked front room support for FDA inspections in Japan and China for parent company and contract manufacturers. • Key member in Health Canada Inspections.• Manage QMS integration for recent corporate acquisition.

• Implemented new processes and made changes to existing processes to ensure compliance to US FDA regulations and ISO Standards.• Provided advice and guidance to Engineering to ensure Design Controls are properly implemented and product designs are correctly translated into Manufacturing.• Review protocols, equipment validations, process validations and design validations.• Lead failure investigations and root cause analyses related to complaints and/or internal non-conformities.• Managed a successful CAPA program.• Successful implementation and maintenance of a Quality System that resulted in registration to ISO 13485-2003 through TUV Rheinland of North America.• Successfully responded to any FDA 483 observations as well as any TUV Surveillance Audit deviations.• Performed Discrepant Material, Customer Complaint and CAPA quarterly audits.• Conducted Abbreviated and Annual Management Reviews.• Represented Bio-Detek as head auditee in all internal and regulatory body audits.• Particular expertise includes:o Design/Document and change controlo Non-Conforming material, complaint handling and CAPAo Development of Standard Operating Procedures to support business processes.o Compilation of Technical Fileso Knowledgeable in CE Marking of Sterile Product.