Mar Cor Purification
Quality / Regulatory Affairs Manager
September 2008 — Present
Designer/Manufacturer of RO Water Treatment and Purification Systems: (Medical and Commercial). Reporting to Sr. V.P. of Regulatory Affairs in US and Site Operations Manager.
Responsible for overall implementation and site harmonization of our Canadian operations (Burlington, Oakville, and Montreal) Quality Management System (QMS) to be in compliance with applicable U.S. and Canadian Regulatory standards including ISO9001:2008, ISO13485, Health Canada CMDCAS and FDA.
• Organize and schedule quarterly Quality Management Reviews and serve as lead for Internal System and 3rd Party Audits for multiple facilities in Canada.
• Administer and maintain CAPA system and act as Canada CAPA coordinator.
• Responsible for launch, validation and maintenance of QCBD Integrated Quality Management Software within the Burlington manufacturing facility.
• Direct Product Submissions for US FDA 510k and Health Canada Device Licensing.
• Creation of Validation Plans and FMEA’s for RO & DI Water Purification Systems
• Review /Approval of all Validation Protocols ensuring compliance to Design/Contract requirements.
• Executor of MCP Burlington Risk Management and Continuous Improvement Program, ensuring compliance to 14971.
• Responsibility for post-market surveillance and reporting of adverse events to management and appropriate regulatory agencies.