quality-manager-qmr
tessl i github:alirezarezvani/claude-skills --skill quality-manager-qmrSenior 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.
Activation
67%The description adequately covers the 'what' and 'when' with an explicit use clause, earning good completeness marks. However, it relies on somewhat abstract management-level language rather than concrete actions, and could benefit from more specific trigger terms that users in the medical device industry would naturally use. The domain focus on HealthTech/MedTech provides some differentiation but could be strengthened with industry-specific terminology.
Suggestions
Add concrete specific actions like 'conduct management reviews', 'approve CAPA closures', 'sign off on design history files', 'oversee supplier audits' to improve specificity.
Include industry-standard trigger terms users would naturally say: 'ISO 13485', 'FDA 21 CFR Part 820', 'QMS', 'CAPA', 'audit findings', 'design controls', 'MDR compliance'.
| Dimension | Reasoning | Score |
|---|---|---|
Specificity | Names the domain (HealthTech/MedTech quality management) and lists some actions like 'regulatory compliance oversight' and 'strategic quality leadership', but these are high-level categories rather than concrete specific actions like 'conduct management reviews' or 'approve CAPA closures'. | 2 / 3 |
Completeness | Clearly answers both what (quality system responsibility, regulatory compliance oversight, management accountability, strategic quality leadership) and when with explicit 'Use for' clause specifying quality system governance, regulatory compliance oversight, management responsibility, and quality strategic planning. | 3 / 3 |
Trigger Term Quality | Includes some relevant terms like 'QMR', 'quality system', 'regulatory compliance', 'HealthTech', 'MedTech', but misses common variations users might say like 'ISO 13485', 'FDA compliance', 'quality manual', 'audit', 'CAPA', or 'QMS'. | 2 / 3 |
Distinctiveness Conflict Risk | The HealthTech/MedTech focus and QMR role provide some distinctiveness, but terms like 'regulatory compliance' and 'quality system' could overlap with general compliance or quality assurance skills not specific to medical devices. | 2 / 3 |
Total | 9 / 12 Passed |
Implementation
7%This skill content functions more as a comprehensive quality management role description than an actionable skill for Claude. It extensively describes QMR responsibilities, frameworks, and organizational structures but provides no concrete guidance, executable code, or specific procedures Claude could follow. The content assumes Claude needs education on quality management concepts rather than specific instructions for tasks.
Suggestions
Replace abstract responsibility descriptions with specific, executable procedures (e.g., 'To prepare a management review report: 1. Run `python scripts/qmr-dashboard.py --quarter Q1` 2. Review output for KPIs below threshold...')
Add concrete code examples for the referenced scripts showing actual implementation and expected outputs
Convert the responsibility matrices into decision trees or checklists with specific trigger conditions and actions (e.g., 'IF compliance gap identified THEN: 1. Document in [template], 2. Assess severity using [criteria], 3. Escalate if severity > X')
Remove explanatory content about what QMR responsibilities are and focus on how Claude should execute specific QMR tasks when requested
| Dimension | Reasoning | Score |
|---|---|---|
Conciseness | Extremely verbose with extensive organizational frameworks, matrices, and lists that describe concepts Claude already understands. The content reads like a quality management textbook rather than actionable instructions, with significant padding around obvious concepts like 'Quality Policy: Top-level quality commitment and direction'. | 1 / 3 |
Actionability | Almost entirely abstract and descriptive with no concrete code, commands, or executable examples. References scripts like 'qmr-dashboard.py' but provides no actual implementation. Statements like 'Ensure comprehensive regulatory compliance' and 'Foster organizational quality culture' are vague directives without specific steps. | 1 / 3 |
Workflow Clarity | While numbered lists exist, they describe categories and responsibilities rather than actionable workflows. No validation checkpoints, no feedback loops, and no clear sequencing for multi-step processes. The 'Strategic Planning Process' lists topics but not how to actually execute them. | 1 / 3 |
Progressive Disclosure | References external files in a Resources section with clear organization (scripts/, references/, assets/), but the main content is a monolithic wall of text with extensive inline detail that could be split into separate reference documents. The structure exists but content organization is poor. | 2 / 3 |
Total | 5 / 12 Passed |
Validation
81%| Criteria | Description | Result |
|---|---|---|
description_trigger_hint | Description may be missing an explicit 'when to use' trigger hint (e.g., 'Use when...') | Warning |
metadata_version | 'metadata' field is not a dictionary | Warning |
license_field | 'license' field is missing | Warning |
Total | 13 / 16 Passed | |
Reviewed
Table of Contents
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