Paige Elizabeth Sutton

Project Associate

Paige is a Quality Management and Regulatory professional with 10 years track record in the medical device industry. Her expertise includes product design and development, process validations, V&V, complaint handling, QC strategies, QMSdeployment, and auditing to FDA 21 CFR 820 / ISO 13485. She is experienced in maintaining QMS certification and FDA approvals for invasive and implantable products such as surgical spinal and orthopedic implant systems, products with neurological applications, and also textile products. Paige holds a BSc in Material Science and Engineering from Lehigh University (PA), is Lean Six Sigma Black Belt, and ASQ certified as a Certified Quality Engineer. Also, Paige is certified as a NAMSA Regulatory Toxicology specialist. Paige assists clients with product design and development of upper-classes medical devices, complex process control, and deployment/maintenance of QMS, including execution of audits and suppliers follow-up.