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Client identities are deleted from the following case descriptions to protect confidentiality. Client information is not disclosed without explicit authorization. |
Prepared three Canadian Medical Device Companies for successful, first audit, registration to ISO 13485 as required by the Canadian Medical Devices Regulations.
Implemented and managed ISO 9001 compliant quality systems, closely integrated with environmental and safety management plans, on $650M highway design-build-operate project.
Designed and implemented an efficient ISO 9001 compliant Quality Management System for installer of epoxy industrial floors.
Designed and implemented Quality Management Systems for numerous manufacturing companies in a variety of fields.
Analyzed quality system requriements and drafted ISO 9001 compliant quality system documentation for the winning proposal on a major highway project. Analyzed conflicting and ambiguous requirements leading to major savings for the developer.
Developed process documentation and deployment methodologies for an international consumer product manufacturer.
Coordinated capability studies, recommended practices, trained quality manager and clarified subcontractor requirements for new automotive part project.
Consultant and trainer in implementation and registration projects for: ISO 9001- Leading Canadian designer and manufacturer of metal roll forming machinery, Designer/producer of consumer packaging; ISO 9002 - Major Ottawa plastics mould maker and injection moulder, Toronto area roll former, Printed circuit board producer, Multi-plant pigment and chemical manufacturer; QS 9000: Tier 1 automotive electronics manufacturer.
Conducted pre-registration assessments for companies in paper, software, textiles, electronics, automotive parts, household products, pigments, chemicals and packaging.
Lead consultant for productivity and quality improvements for custom orthotics manufacturer.
Advised and coached management of a window products company in a participative, company-wide, continuous improvement program featuring improved results reporting, increased employee participation and benchmarking exchanges.
We have written and delivered customized General Orientation, Statistical Process Control (SPC), Quality Improvement, Team Problem Solving, Quality Function Deployment and ISO 9000 courses for clients in various industries, including aerospace, automotive, packaging, chemicals and foods.
Designed, wote and conducted successful ISO 13485 seminars for member companies of MEDEC.