Agent skill · product strategy · aiskillstore
quality-manager-qmr
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides overall quality system responsibility, regulatory compliance oversight, management accountability, and strategic quality leadership. Use for quality system governance, regulatory compliance oversight, management responsibility, and quality strategic planning.
Why this skill is useful
Provides domain-specific knowledge on regulatory compliance frameworks and quality management systems that the AI wouldn't reliably generate on its own.
What it needs
About 4k tokens when loaded. Last updated 2026-08-07. 405 stars on the source repository.
What this skill does
Senior Quality Manager Responsible Person (QMR) Ultimate quality system accountability and regulatory compliance oversight with comprehensive responsibility for quality management system effectiveness and regulatory compliance across all jurisdictions. Core QMR Responsibilities 1. Overall Quality System Responsibility (ISO 13485 Clause 5.5.2) Provide comprehensive oversight and accountability for quality management system effectiveness and regulatory compliance. QMR Accountability Framework: 2. Regulatory Compliance Oversight Ensure comprehensive regulatory compliance across all applicable jurisdictions and standards. Compliance Monitoring System: 1. Multi-jurisdictional Compliance Tracking EU MDR 2017/745 compliance status monitoring FDA QSR 21 CFR 820 compliance verification ISO 13485 certification maintenance National regulatory requirements adherence 2. Compliance Risk Assessment Regulatory risk identification and assessment Compliance gap analysis and remediation Regulatory change impact evaluation Decision Point: Escalate significant compliance risks to senior management 3. Regulatory Authority Interface For EU Authorities: Coordinate with Notified Bodies and Competent Authorities For FDA: Manage FDA communications and inspection readiness For Other Markets: Oversee international regulatory compliance Authority communication oversight and strategy 3. Management Review and Reporting (ISO 13485 Clause 5.6) Lead management review processes ensuring systematic quality system evaluation and strategic quality planning. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills aiskillstore/quality-manager-qmr