Daniel Fenton
Director of Regulatory Compliance and Quality Assurance @CooperVision
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WORK HISTORY
Director of Regulatory Compliance and Quality Assurance @CooperVision
Rochester, NY, US
Serve as QMS Management Representative, leading regulatory and quality compliance for a global medical device manufacturer.• Spearheaded quality transformation initiatives resulting in a 70% reduction in site defects per million and a 79% reduction in complaints.• Drive strategic quality planning using the policy deployment-based framework to align data-driven decisions with company objectives.• Lead development of a cross-functional quality engineering team focused on risk management, validation, and process characterization.• Manage and optimize eQMS platforms (Agile, Tableau, Blue Mountain, InfinityQS), ensuring validated and compliant digital quality processes.• Represent site interests in global quality and regulatory forums, contributing to harmonization efforts across business units.
EDUCATION
SUNY Geneseo
BS, Physics, Mathematics, Computer Science
Rochester Institute of Technology
Master of Science (MS), Sustainable Systems
SKILLS
ABOUT DANIEL FENTON
I\'m a seasoned Quality & Regulatory executive with over 15 years of experience driving enterprise-wide compliance, QMS implementation, and continuous improvement within the medical device industry. I specialize in leading cross-functional teams to build and optimize quality systems aligned with ISO 13485, FDA 21 CFR Part 820, MDSAP, and EU MDR standards.My leadership has resulted in measurable improvements: reducing site defects by 70% and complaints by 79% while building high-performing quality teams and harmonizing global quality processes. I’ve led successful regulatory audits, implemented validated eQMS and ERP software and tools (Grand Avenue Software, IQMS, Critical Manufacturing, Agile, Tableau, Blue Mountain), and championed a data-driven approach to strategy execution through Policy Deployment.I\'m passionate about fostering a proactive quality culture that aligns business objectives with compliance and operational excellence. Let’s connect if you\'re driving innovation in medtech or looking for quality leadership.
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