Quality Manager Qmr

This one handles the top-level quality management role for HealthTech and MedTech companies, covering ISO 13485 Clause 5.5.2 responsibilities like QMS oversight, regulatory compliance across EU MDR and FDA QSR, and management reviews. It's built for quarterly C-level reporting, managing relationships with Notified Bodies and FDA, and running audit programs. Use it when you need strategic quality decisions rather than day-to-day quality operations. The framework is solid for multi-jurisdictional compliance tracking, though you'll still need domain experts for specific regulatory submissions. Good fit if you're setting up quality governance or preparing for regulatory inspections.

skills.sh installs: 290
GitHub stars: 33.2K
last updated: Aug 21, 2026

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Install

$ npx -y skills add davila7/claude-code-templates --skill quality-manager-qmr --agent claude-code

Installs into .claude/skills of the current project.

Files

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.