Quality Manager QMR
Skill Verified ActiveSenior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
To provide expert-level guidance and structure for Quality Managers Responsible Persons (QMRs) in HealthTech and MedTech companies, ensuring robust quality system governance and regulatory compliance.
Features
- Quality system governance
- Management review leadership
- Regulatory compliance oversight
- Quality performance monitoring
- ISO 13485 Clause 5.5.2 adherence
- Detailed workflows and templates
Use Cases
- Conducting ISO 13485-compliant management reviews.
- Establishing and monitoring quality KPIs.
- Setting and tracking quality objectives.
- Overseeing regulatory compliance across jurisdictions.
Non-Goals
- Replacing a human QMR
- Providing legal advice
- Automating all QMS processes without human input
Practices
- Quality system governance
- Regulatory compliance
- Management review
- KPI management
- Risk management
Prerequisites
- Understanding of ISO 13485
- Python 3 (for included script)
Installation
First, add the marketplace
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skillsQuality Score
VerifiedTrust Signals
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