Dan Fullerton
VP Operations, Quality and Compliance at SHOEBOX Ltd.- Claim this Profile
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English -
Topline Score
Bio
Credentials
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Past Certifications - ASQ CMQ/OE, ASQ CQE, ASQ CRE
ASQ
Experience
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SHOEBOX Ltd.
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Canada
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Medical Equipment Manufacturing
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1 - 100 Employee
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VP Operations, Quality and Compliance
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Jan 2017 - Present
Responsible for Operations, Quality and Compliance for SHOEBOX Audiometry, the leading mobile, clinically validated audiometry solution. We are hiring - check out our careers page www.shoebox.md/careers Responsible for Operations, Quality and Compliance for SHOEBOX Audiometry, the leading mobile, clinically validated audiometry solution. We are hiring - check out our careers page www.shoebox.md/careers
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DNA Genotek
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Canada
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Biotechnology Research
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100 - 200 Employee
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VP Operations, Quality and Regulatory Affairs
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Aug 2012 - Dec 2016
August 2012 - December 2016- Enabled revenue growth from US$14M to US$30M, 50% CAGR.- Lead team of 22 managers and individual contributors for all engineering, maintenance, training, document control, inventory, production planning, purchasing, shipping, receiving, quality assurance, quality control and regulatory affairs activities. - Obtained 3 FDA 510k clearances & EU CE IVD registrations for new products.- Established strong relationships with key contract manufacturing partners.- Contracted, installed and validated 3 high volume automated assembly lines at Contract Manufacturing partners.- Maintained ISO 13485/ISO 9001/ FDA GMP compliant quality management system, annual audits by regulators & registrar.- Led corrective action & remediation activities related to Design Controls as result of FDA warning letter.- Managed global regulatory registrations & compliance (100+ countries). Show less
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Quality Manager
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Mar 2009 - Aug 2012
- Quality and Operations leader with responsibilities typical of a small company (QMS, engineering, document control, configuration management, formulations and assembly manufacturing).- Maintained ISO 13485 Quality Management System and expanded scope to include FDA GMP compliance. - Developed equipment qualification and process validation processes & conducted retrospective validations of existing manufacturing processes.- Led evolution of key business processes (NPI, order fulfillment, configuration management, etc) as requirements evolved & business scaled. Show less
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JDSU
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Telecommunications
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1 - 100 Employee
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Customer Quality Engineer
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Apr 2007 - Mar 2009
- Serviced critical account customers as part of multi-disciplinary team.- Crisis management and problem solving.- Analyzed and presented quality metrics/scorecards to customers & management.- Supported customer audits of Asian manufacturing operations.
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Quality Engineer
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Jul 2004 - Mar 2007
- Led all aspects of quality planning for products through Product Development process.- Led Failure Modes and Effects Analysis, process capability evaluations, Design of Experiment, and Quality Function Deployment activities for assigned advanced modules products.- Continued leadership of quality and yield improvement initiatives with critical optics component suppliers in North America and Asia.- Transferred manufacturing from Ottawa to Asian manufacturing operations.
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Supplier Quality Engineer
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Oct 2000 - Jun 2004
- Managed Supplier Quality portfolio for active and passive optical components.- Analyzed and presented quality metrics/scorecards to suppliers and management.- Developed suppliers through in-depth audits to identify weakness & drive improvement plans.
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Education
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1994 - 2000
University of Saskatchewan
B. Engineering, Electrical
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