Paige Sutton-Smith

Paige Sutton-Smith is a Quality Management and Regulatory professional with 12 years track record in the medical device industry. Her expertise includes US regulatory approval, product design and development, process validations, V&V, complaint handling, QC strategies, QMS deployment, and auditing to FDA 21 CFR 820 / ISO 13485. She is experienced in maintaining QMS certification and FDA approvals for invasive and implantable products. Paige holds a BSc in Material Science and Engineering from Lehigh University (PA), achieved a RAC-Devices certification, is a Lean Six Sigma Black Belt, and ASQ certified as a Certified Quality Engineer. Also, Paige is certified as a NAMSA Regulatory Toxicology specialist.