Carmelo Foti Email and Phone Number

Manager at Cook Medical | ISO 13485 and Process ValidationManager at Cook Medical | Biotech and IVD Manufacturing ExpertBiotech Manufacturing Manager with Quality Risk Management TrainingAs a Manager at Cook Medical, I lead a team of professionals in producing high-quality medical devices and products for the life science sector. I have over 10 years of experience in biotech and IVD manufacturing, with credentials in ISO 13485, Process Validation, and Quality Risk Management.I excel at supervising, planning, and coordinating production resources, schedules, and material requirements, as well as managing design transfer processes internally and externally. I also ensure compliance with cGMP, validation, and environmental standards, and participate in quality systems activities such as CAPA, risk management, supplier evaluation, and audits. I am passionate about stakeholder engagement, continuous improvement, and lean six sigma principles, and I have successfully implemented change and project management initiatives to achieve cost, supply, quality, and safety targets. I am a quality-focused, energetic, and professional leader, who strives to learn and grow, and to establish positive relationships and outcomes in business.