Wayne Coady

Background

About Wayne Coady

Senior Quality Engineer with over two decades of experience in the healthcare and medical device industries, combining hands-on quality systems expertise with a strong focus on leadership, strategic improvement, and regulatory excellence. Currently at West Pharmaceutical Services, I lead initiatives in contamination control, laboratory quality, and sterilisation strategy, while also serving as a key approver for batch release ensuring each product meets regulatory, GMP, and internal quality standards. I work closely with Operations, Labs, and Engineering teams to drive timely resolutions, reduce deviations, OOS and enhance overall product reliability. My background spans the full product lifecycle, from new product introduction and validation through to audit readiness and continuous improvement. I have supported compliance with FDA, ISO, and EU regulations in fast-paced, high-stakes environments where product quality is critical to patient outcomes. Academically, I hold a Master’s Degree in Quality (Level 9) from Atlantic Technological University (Sligo), where I completed a thesis on “Exploring the Influence of Leadership on Organisational Quality Culture in a Medical Technology Company.” I also hold an Engineer’s Degree (Level 8) in Quality and Regulatory Affairs from the University of Limerick. I’m passionate about building strong quality cultures, leading cross-functional collaboration, and aligning quality goals with wider business strategy. My ambition is to continue progressing into leadership roles where I can help shape systems that not only ensure compliance but also drive excellence and strengthen patient trust across the value chain.