About you: You are a detail-oriented quality professional with robust medical device experience and a track record of owning Quality Management Systems end to end. You're comfortable serving as the eQMS subject matter expert and business process owner, balancing compliance requirements with business objectives in a fast-paced product development and manufacturing environment. You bring strong leadership, stakeholder management, and analytical skills, and you're motivated to embed quality and compliance across R&D, Manufacturing, Operations, and Supply Chain. What you'll do: Own, maintain, and continuously improve the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA QMSR, MDSAP, Health Canada Medical Device Regulations, and other applicable global requirements. Serve as business owner and administrator of the eQMS, configuring and optimizing workflows, forms, permissions, training curricula, and dashboards. Lead eQMS implementations, upgrades, enhancements,



and validation activities, partnering with IT and external vendors on system performance and compliance. Plan and manage internal quality audits, and coordinate external audits, certification audits, customer audits, and regulatory inspections. Oversee CAPA, deviation, nonconformance, and change control processes, ensuring effective root cause investigations and monitoring quality trends. Lead Management Review activities, developing and maintaining quality dashboards and performance metrics for senior leadership. Ensure effective document control processes, including creation, approval, revision, and archival of quality system documents and training records. Support product development activities in accordance with design control requirements, including design reviews, verification, validation, and design

📌 Quality Systems Manager (Oakville)
🏢 Socket.dev
📍 Oakville