quality-manager-qmr

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.

1.26x

Quality

35%

Does it follow best practices?

Impact

95%

1.26x

Average score across 6 eval scenarios

Securityby

Passed

No known issues

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Evaluation results

100%

23%

Semi-Annual Management Review Package Preparation

Management review preparation and tracker script usage

Criteria

Without context

With context

8-section input template

100%

Tracker script executed

100%

Action item ID format

100%

2-week notification timing

100%

All required attendees listed

75%

100%

1-week agenda distribution

37%

100%

Review outputs documented

87%

100%

Metrics in review_data.json

75%

100%

Prior action items tracked

62%

100%

Input readiness by topic

100%

Review period stated

100%

CAPA data included

100%

87%

24%

Quality KPI Framework for New Medical Device Startup

Quality KPI framework with SMART criteria and performance response

Criteria

Without context

With context

SMART criteria applied

Owner per KPI

100%

Escalation criteria per KPI

100%

First Pass Yield target

100%

CAPA targets correct

100%

Complaint Rate target

100%

Customer Satisfaction target

100%

Review frequency by type

50%

Performance Response Matrix

20%

100%

Current-state assessment accuracy

75%

100%

Data source per KPI

100%

NCR and Repeat Finding targets

100%

32%

Annual Quality Planning: Objectives, Cost Analysis, and Initiative Prioritization

Annual quality objectives, cost of quality, and investment prioritization

Criteria

Without context

With context

Objective numbered format

71%

100%

All objective fields present

50%

100%

Supporting initiatives field

40%

100%

Objective validation met

100%

Four CoQ categories

100%

CoQ as % of revenue

37%

100%

Prevention/Appraisal ratio

37%

100%

Failure cost ratio

62%

100%

Prioritization weights used

33%

100%

Scores shown per criterion

100%

Ranked recommendation

100%

Resource requirements field

87%

100%

95%

-2%

Quality Culture Health Check

Quality culture assessment and improvement planning

Criteria

Without context

With context

All 6 dimensions covered

100%

Response rate validation

100%

Bottom 3 dimensions targeted

100%

Low reporting gap addressed correctly

100%

Communication gap addressed correctly

100%

Two-week response window

100%

Results analysis by segment

100%

Leadership visibility action

100%

Actions have owners

100%

5 category survey structure

62%

37%

Confidentiality communicated

100%

92%

11%

Regulatory Change Management and Inspection Preparation

Regulatory compliance monitoring and inspection readiness

Criteria

Without context

With context

All 8 readiness areas checked

100%

Correct gaps identified

100%

90-day process update deadline

90%

Monthly impact assessment

70%

30%

Training verification required

100%

Remediation prioritized for audit

100%

Action owners assigned

100%

Compliance status tracking

100%

Affected processes mapped

100%

Regulatory requirement register reference

100%

Readiness checklist format

100%

35%

QMR Decision Triage and Reporting Governance

QMR escalation decisions and resource allocation authority

Criteria

Without context

With context

Regulatory violation escalated immediately

100%

Safety issue escalated to safety team

40%

100%

Multi-department issue escalated to executive

100%

Single-department issue handled at department level

100%

Equipment request within QMR authority

100%

Consultant within QMR authority

100%

Quality system requires executive approval

100%

Consultant duration escalation

75%

100%

Reporting cadence in governance charter

70%

100%

Authority boundaries documented

75%

100%

Escalation logic documented

66%

100%

Dollar thresholds cited

50%

100%

Repository: alirezarezvani/claude-skills
Commit: 967fe01

Evaluated: 25 days ago
Agent: Claude Code
Model: Claude Sonnet 4.6

Table of Contents

Semi-Annual Management Review Package Preparation Quality KPI Framework for New Medical Device Startup Annual Quality Planning: Objectives, Cost Analysis, and Initiative Prioritization Quality Culture Health Check Regulatory Change Management and Inspection Preparation QMR Decision Triage and Reporting Governance

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