I assist organizations to shift to more robust, organization-focused. process controls, efficiently build quality management systems, streamline activities, reduce bureaucracy, and explore opportunities for growth. Although currently focused on upcoming shifts in the EU medical manufacturing world - as In Vitro Diagnostics compliance needs merge with the regulatory changes the MDR and IVDR present, I support a range of QMS and GMP systems. I assist in planning system creation, implementation, continual improvement, and ongoing organization-focused quality management and internal auditing.

Reported to PresidentIn a dual industrial/neonatal chemical analysis equipment/reagent manufacturing facility, with assistance of a multi-faceted group of 8-10 direct reports, and direct involvement with Engineering, Applications, Customer Service, Sales, Product Development, Regulatory Affairs, Finance, and Service, I expanded personnel management scope to additionally motivate and organize Purchasing/Planning, Materials Management, Supply Chain Management and Shipping/Receiving.Embracing multiple in-vitro diagnostics medical device manufacturing regulatory directives, enabled a dual warehoused facility to successfully manage parts planning, purchasing, shipping, receiving, warehousing, supplier/parts control, labor distribution, change control, continual risk analysis, and troubleshooting. Met both in house lab and support needs, facilities expansion, and timely delivery to a robust customer base demanding a wide range of technology, creativity and support.

Reported to PresidentMet operating systems, customer service, materials warehousing, product development, timely delivery/receipt demands, planning goals and implementation training, through mgt of Planning, Customer Service, Inventory Management, Reagent and Hardware Manufacturing, Parts and Consumables Production, Repair, and Quality Control - wihin a dual Industrial/Neonatal chemical analysis equipment/reagent manufacturing facility. Managed quality improvements via non conformance data gathering and analysis, establishing corrective/preventive actions, and quality improvement implementation and planning. Saw product design through to release, managing processes to compliance, meeting ISO 13485:2003, CFR Part 820, Canadian Medical Device Regulations (SOR-98-282) and European In vitro Diagnostics Directive (98/79/EC) standards. Performed selected internal audits. Oversaw goods movement from Incoming Inspection to release. Planned and documented Process Validations, Failure Mode and Effects Analyses, Engineering Change Orders, Corrective Actions, while continually refining process controls.

Reported to Operations DirectorDeveloped and managed documentation supporting standard operating procedures, Device History Files, quality control, production process, instrument/reagent in-vitro diagnostics development, incoming, in-process and final inspections, bill of materials, Device Master Records, work orders, conformance data and training. Established maintenance plans. Implemented ongoing new product assimilation into manufacturing lines, controlling identification, storage specifications, expiry sensitive warehousing, personnel training, and company-wide awareness events.Alongside Regulatory Affairs, and in a short period of time, designed and implemented production processes and a robust document control compliance structure to support a regulated Quality Management System. Received the 2010 President’s Award for achievement. Managed all hardware, reagent, repair, parts and consumables production and quality control personnel.

Reported to Vice President of Finance/OperationsMet shipping and receiving demands, and managed all inventory control and movement of temperature and time sensitive goods.Directly assisted Procurement, Inventory Control, Design, Applications, Service, Materials, Finance, Sales and Production to meet daily goals. Encouraged and led teams to establish all inventory controls, preparing database entry methods, work order and routing infrastructures, manufacturing bill of materials, inventory reporting and assessment methods, service parts management, supportive data acquisition (internal and external drivers), and trending methods. Encouraged inter-departmental communications. Supported the growth of work instruction drafting/training/publishing, production line improvements, hazardous materials handling, labeling controls, storage methods, and product development input towards realization.

Reported to Captain, Island Enterprise F/TManaging officer for vessel’s financial operations, human resources (60+ crew), supply ordering/warehousing in a fast paced on-board production facility, with ongoing challenges and hazards. Began career as a Roe Grader.