quality-manager-qmr

Quick Review

High-quality skill providing comprehensive Senior Quality Manager Responsible Person (QMR) capabilities for HealthTech/MedTech regulatory compliance and quality system governance. The description clearly covers core QMR responsibilities including ISO 13485 compliance, multi-jurisdictional regulatory oversight (EU MDR, FDA QSR), management review leadership, and quality culture development. Task knowledge is extensive with detailed frameworks for compliance monitoring, strategic planning, KPI management, and regulatory authority interface. Structure is well-organized with logical sections covering accountability, governance, performance monitoring, and strategic integration. References to supporting scripts (qmr-dashboard.py, regulatory-compliance-tracker.py) and reference materials enhance completeness. Novelty is strong as this specialized regulatory compliance role requires deep domain expertise across multiple jurisdictions and quality standards that would be challenging for a CLI agent to replicate without this structured knowledge base. The skill effectively reduces token costs by consolidating complex regulatory frameworks, compliance matrices, and quality governance processes into reusable templates and decision points. Minor improvements could include more specific invocation examples for different compliance scenarios, but overall this is a robust, domain-specific skill with clear practical application.