Amy Cameron

Background

About Amy Cameron

With 20+ years in contract medical device manufacturing, I bring a systems-level view of quality leadership built on hands-on experience across QA, R&D, and manufacturing operations. I’ve advanced from operator to site quality leader, giving me the ability to connect floor-level realities with big-picture compliance and business objectives. My Bachelor’s degree in Biology, with a focus in Microbiology, gave me the academic foundation to understand sterility assurance, contamination control, and method development at a deep level. Combined with decades of applied experience, this background allows me to bridge science, operations, and compliance in a way that ensures both regulatory robustness and practical implementation. Leadership & Quality Systems I specialize in ISO 13485 and FDA 21 CFR 820/11 compliance, leading projects from concept through commercial launch and sustained manufacturing. Experienced in equipment qualifications, IQ/OQ/PQ process validations, packaging validations, pFMEA, and risk analysis, I focus on driving improvements that are both regulator-ready and operationally efficient. I’ve successfully led audits and inspections with FDA, ISO/Notified Bodies, EPA, and customers, ensuring both compliance and strong client relationships. Sterility Assurance & Microbiology Alongside my leadership experience, I bring deep technical expertise in microbiology and sterility assurance-Sterilization validations for EO, Steam, Gamma, and Dry Heat-Cleaning and dry-time validations for reusable devices-Microbiological method development and validation (bioburden, sterility, endotoxins, EO residuals, preservative effectiveness)-Environmental monitoring and cleanroom qualifications to ISO 14644. Proven Impact I’ve collaborated with customers to bring innovative devices to market, including injectable systems and active implants. I am an inventor on two patents for viscous injectable delivery systems, shepherding them from concept through R&D, regulatory approval, and into full-scale commercial manufacturing. I thrive where product quality, regulatory compliance, and operational efficiency intersect, and I am dedicated to building or improving quality systems that are as practical on the floor as they are defensible in audits.