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  1. 1. Jim Graham Page 1 of 2 Jim Graham 155 Lindylou Road Toronto, ON M9M 2B8 H (416) 741-7724 Summary: Quality Systems expert with over 25 years experience in various sectors. Fully conversant with ISO 13485 and FDA Cfr Part 820, took the lead role in managing and maintaining the overall site quality system, ensuring compliance and high product quality. Also led product change, and problem investigation/correction for TRUGENE product hardware and glass consumables. Computer literate and familiar with e-systems for ERP, document control, engineering change, Microsoft Office, CAPA, complaints and supplier management. In addition, wide hands-on experience in urban agriculture with an emphasis on educating children. Since 2010, wide experience in Panorama Community Garden (volunteer and paid positions). Currently, developing and delivering gardening and ecology lessons to children in garden and school settings, funded by the Weston Parks Family Challenge. PROFESSIONAL WORK EXPERIENCE: SIEMENS CANADA HEALTHCARE-DIAGNOSTICS, TORONTO, ON. 2000-2015 Quality Assurance Specialist  Site Quality Management Representative. External QMS audit leader for ISO 13485 and FDA CFR 820 compliance audits. Led response to findings post-external QMS audits.  Site internal audit program coordinator. Assisted with audit program in Berkeley CA location as needed.  Site CAPA administrator, leading all phases of CAPA process; CARB coordinator for Molecular Business Unit; staff training in CAPA processes; assisted CAPA completion in Berkeley CA.  Site document control coordinator; backup for Molecular document control in Berkeley CA. Managed transfer of Toronto documentation system into Lotus Notes platform 2004, and assisted with same for Elkhart IN branch 2006.  Managed engineering change for TRUGENE hardware and consumables; Updated and maintained BOM for hardware/consumables 2004 - 2015.  Coordinated investigation of hardware/MicroCel customer complaints for TRUGENE product line; Lead quality contact with contract manufacturer and main suppliers; participated in product support team process and product problem meetings.  Oversaw defect trending projects for the Toronto site.  Prepared data and presentations for quarterly Molecular Business Unit Management Review.  Also supervised up to seven QC Inspectors (2000 to 2003). Amphenol Canada Ltd, Toronto 1998-2000 Lead Hand Inspector Quinton Electrophysiology, Richmond Hill 1995, 1997 - 1998 Senior Quality Inspector Generics [UK], Potter Bar, UK 1988 – 1993 Supervisor, Printed Materials Store Waddington and Duval Ltd, Putney, UK 1986 - 1988 QC Inspector, Assembler
  2. 2. Jim Graham Page 2 of 2 EDUCATION AND PROFESSIONAL TRAINING:  B.A. (Honours) Economics – York University, Toronto, 1981  Certificate in Supervisory Management – Barnet College, London, 1992  Business Diploma – Middlesex University, London, 1993  PC Certificate – Humber College, Toronto, 1994  Quality Assurance Certificate - Seneca College, Toronto, 2000 HORTICULTURE BACKGROUND:  Develop and lead seasonal native plant tours and workshops at Humber Arboretum – 2011 to present.  Volunteer and gardening advisor, Panorama Community Garden – Oct 2010 to present o Active participant in garden design, planning and realization; event planning and execution.  Develop and lead regular lessons in growing vegetables for children ages 7 to 12 – 2012 to present o 2012 – Trial program at Panorama Community Garden. o 2013 – Panorama CG, Albion Library. o 2014 – Panorama CG, Albion Library, 3 local schools and 3 summer camps.  Founded Rexdale Community Gardening Network (Rexdale Community Health Centre, Panorama CG, Albion Library, 4 local schools) – 2013.  Weston Parks Family Challenge grant 2015 (ongoing) – Environmental Coordinator for summer gardening/ecology camps for children; events; workshops; curriculum material development and delivery. HORTICULTURAL TRAINING:  Horticulturalist Certificate (online, 7 courses) – University of Guelph, 2007.  Garden Design I, II and II (online) – U of Guelph, 2012.  Woodland Ecology (online course) – U of Guelph, 2014. GROUP MEMBERSHIPS:  Etobicoke Master Gardeners – 2008 to present.  Ontario Rock Garden and Hardy Plant Society – 2012 to present.  Etobicoke Horticultural Society – 2011 to 2012.  Rexdale Community Garden Network (founder) – 2013 to present.  Park People Advisory Committee – 2016  Toronto Urban Growers - 2016