Skill · em Documentar e entregar

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,…

Procedência

Antes de instalar

4 arquivos · 12,1 KB · inclui 1 script que executa: scripts/example.py

Instalar na sua CLI

O comando baixa a versão fixada (commit 57f899e) direto da origem, para a pasta que a CLI lê. Precisa de curl (macOS e Linux); no Windows não há comando, porque o Rook Labs é para macOS.

Claude Code

Neste projeto: instala em .claude/skills/quality-manager-qmr/.

d=".claude/skills/quality-manager-qmr"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qmr"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.claude/skills/quality-manager-qmr/.

d="$HOME/.claude/skills/quality-manager-qmr"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qmr"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Codex

Neste projeto: instala em .agents/skills/quality-manager-qmr/.

d=".agents/skills/quality-manager-qmr"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qmr"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.agents/skills/quality-manager-qmr/.

d="$HOME/.agents/skills/quality-manager-qmr"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qmr"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Antigravity

Neste projeto: instala em .agents/skills/quality-manager-qmr/.

d=".agents/skills/quality-manager-qmr"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qmr"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Global: instala em ~/.gemini/antigravity-cli/skills/quality-manager-qmr/.

d="$HOME/.gemini/antigravity-cli/skills/quality-manager-qmr"
u="https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/cli-tool/components/skills/enterprise-communication/quality-manager-qmr"
curl -fsSL --create-dirs \
  -o "$d/SKILL.md" "$u/SKILL.md" \
  -o "$d/assets/example_asset.txt" "$u/assets/example_asset.txt" \
  -o "$d/references/api_reference.md" "$u/references/api_reference.md" \
  -o "$d/scripts/example.py" "$u/scripts/example.py" \
  -o "$d/LICENSE" "https://raw.githubusercontent.com/davila7/claude-code-templates/57f899e5394bb8ca166f38eacae8f0853cbfe033/LICENSE"

Peça ao Rook

Já usa o Rook Labs? Cole no chat do Rook: instale a skill https://rooklabs.sh/marketplace/cct.quality-manager-qmr

Prévia do SKILL.md

---
name: quality-manager-qmr
description: 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 …
---

# 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:**
```
QMR RESPONSIBILITY MATRIX
├── Quality Management System Oversight
│   ├── QMS effectiveness monitoring
│   ├── Quality policy implementation
│   ├── Quality objectives achievement
│   └── Resource adequacy assessment
├── Regulatory Compliance Oversight
│   ├── Regulatory requirement monitoring
│   ├── Compliance status assessment
│   ├── Regulatory submission oversight
│   └── Authority relationship management
├── Management Responsibility
│   ├── Senior management reporting
│   ├── Quality performance communication
│   ├── Strategic quality planning
│   └── Organizational quality culture
└── Continuous Improvement Leadership
    ├── Quality system enhancement
    ├── Performance improvement initiatives
    ├── Best practice implementation
    └── Innovation and modernization
```

### 2. Regulatory Compliance Oversight
…

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