Quality Manager QMR
技能 已验证 活跃Senior 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.
功能
- Quality system governance
- Management review leadership
- Regulatory compliance oversight
- Quality performance monitoring
- ISO 13485 Clause 5.5.2 adherence
- Detailed workflows and templates
使用场景
- Conducting ISO 13485-compliant management reviews.
- Establishing and monitoring quality KPIs.
- Setting and tracking quality objectives.
- Overseeing regulatory compliance across jurisdictions.
非目标
- Replacing a human QMR
- Providing legal advice
- Automating all QMS processes without human input
实践
- Quality system governance
- Regulatory compliance
- Management review
- KPI management
- Risk management
先决条件
- Understanding of ISO 13485
- Python 3 (for included script)
安装
请先添加 Marketplace
/plugin marketplace add alirezarezvani/claude-skills/plugin install ra-qm-team@claude-code-skills质量评分
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