QMS Consultant

QMS Consultant responsible for planning, scoping, and leading comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manufacturer's Quality Management System (QMS) against ISO 13485:2016 and EU MDR 2017/745, ensuring audit readiness, risk-based compliance, and effective stakeholder communication. Plan, scope, and lead comprehensive mock audits to assess readiness for an upcoming BSI notified body audit. Evaluate the medical device manu…