quality-manager-qmr

Manage — Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversi

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Repository: thiagofernandes1987-create/APEX
Last source activity: April 18, 2026 at 09:35
Detected SKILL.md language: English
Stars: 2
Forks: 0

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SKILL.md

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name	quality-manager-qmr
description	Manage — Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversi
triggers	["management review","quality policy","quality objectives","QMR responsibilities","quality system effectiveness","quality KPIs","cost of quality","quality performance","management accountability","regulatory oversight","quality culture","quality governance"]
executor	HYBRID
skill_id	business.ra-qm-team.quality-manager-qmr
status	ADOPTED
security	{"level":"high","pii":false,"approval_required":true}
anchors	["business","sales","compliance"]
tier	2
input_schema	[{"name":"code_or_task","type":"string","description":"Code snippet, script, or task description to process","required":true}]
output_schema	[{"name":"report","type":"string","description":"Analysis report or summary from quality manager qmr"}]

Senior Quality Manager Responsible Person (QMR)

Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.

QMR Responsibilities
Management Review Workflow
Quality KPI Management Workflow
Quality Objectives Workflow
Quality Culture Assessment Workflow
Regulatory Compliance Oversight
Decision Frameworks
Tools and References

QMR Responsibilities

ISO 13485 Clause 5.5.2 Requirements

Responsibility	Scope	Evidence
QMS effectiveness	Monitor system performance and suitability	Management review records
Reporting to management	Communicate QMS performance to top management	Quality reports, dashboards
Quality awareness	Promote regulatory and quality requirements	Training records, communications
Liaison with external parties	Interface with regulators, Notified Bodies	Meeting records, correspondence

QMR Accountability Matrix

Domain	Accountable For	Reports To	Frequency
Quality Policy	Policy adequacy and communication	CEO/Board	Annual review
Quality Objectives	Objective achievement and relevance	Executive Team	Quarterly
QMS Performance	System effectiveness metrics	Management	Monthly
Regulatory Compliance	Compliance status across jurisdictions	CEO	Quarterly
Audit Program	Audit schedule completion, findings closure	Management	Per audit

Decision Type	QMR Authority	Escalation Required
Process changes within QMS	Approve with owner	Major process redesign
Document approval	Final QA approval	Policy-level changes
Nonconformity disposition	Accept/reject with MRB	Product release decisions
Supplier quality actions	Quality holds, audits	Supplier termination
Audit scheduling	Adjust internal audit schedule	External audit timing
Training requirements	Define quality training needs	Organization-wide training budget

Role	Requirement	Input Responsibility
CEO/General Manager	Required	Strategic decisions
QMR	Chair	Overall QMS status
Department Heads	Required	Process performance
RA Manager	Required	Regulatory changes
Production Manager	Required	Product conformity
Customer Quality	Required	Complaint data

Output	Documentation	Owner
QMS improvement decisions	Action items with due dates	Assigned per item
Resource needs	Resource plan updates	Department heads
Quality objectives changes	Updated objectives document	QMR
Process improvement needs	Improvement project charters	Process owners

Category	KPI	Target	Calculation
Process	First Pass Yield	>95%	(Units passed first time / Total units) × 100
Process	Nonconformance Rate	<1%	(NC count / Total units) × 100
CAPA	CAPA Closure Rate	>90%	(On-time closures / Due closures) × 100
CAPA	CAPA Effectiveness	>85%	(Effective CAPAs / Verified CAPAs) × 100
Audit	Finding Closure Rate	>90%	(On-time closures / Due closures) × 100
Audit	Repeat Finding Rate	<10%	(Repeat findings / Total findings) × 100
Customer	Complaint Rate	<0.1%	(Complaints / Units sold) × 100
Customer	Satisfaction Score	>4.0/5.0	Average of survey scores

KPI Type	Review Frequency	Trend Period	Audience
Safety/Compliance	Daily monitoring	Weekly	Operations
Production Quality	Weekly	Monthly	Department heads
Customer Quality	Monthly	Quarterly	Executive team
Strategic Quality	Quarterly	Annual	Board/C-suite

Performance Level	Status	Action Required
>110% of target	Exceeding	Consider raising target
100-110% of target	Meeting	Maintain current approach
90-100% of target	Approaching	Monitor closely
80-90% of target	Below	Improvement plan required
<80% of target	Critical	Immediate intervention

Category	Example Objectives	Typical Targets
Customer Quality	Reduce complaint rate	<0.1% of units sold
Process Quality	Improve first pass yield	>96%
Compliance	Maintain certification	Zero major NCs
Efficiency	Reduce quality costs	<4% of revenue
Culture	Increase training completion	>98% on-time

Review Element	Assessment	Action
Progress vs. target	On track / Behind / Ahead	Adjust resources if behind
Relevance	Still valid / Needs update	Modify if conditions changed
Resources	Adequate / Insufficient	Request additional if needed
Barriers	Identified obstacles	Escalate for resolution

Dimension	Indicators	Assessment Method
Leadership commitment	Management visible support for quality	Survey, observation
Quality ownership	Employees feel responsible for quality	Survey
Communication	Quality information flows effectively	Survey, audit
Continuous improvement	Suggestions submitted and implemented	Metrics
Training and competence	Employees feel adequately trained	Survey, records
Problem solving	Issues addressed at root cause	CAPA analysis

Category	Sample Questions
Leadership	"Management demonstrates commitment to quality"
Resources	"I have the tools and training to do quality work"
Communication	"Quality expectations are clearly communicated"
Empowerment	"I am encouraged to report quality issues"
Recognition	"Quality achievements are recognized"

Gap Identified	Potential Actions
Low leadership visibility	Quality gemba walks, all-hands quality updates
Inadequate training	Competency-based training program
Poor communication	Quality newsletters, department huddles
Low reporting	Anonymous reporting system, no-blame culture
Lack of recognition	Quality award program, team celebrations

Jurisdiction	Regulation	Requirement	Status Tracking
EU	MDR 2017/745	CE marking, Notified Body	Technical file, annual review
USA	21 CFR 820	FDA registration, QSR compliance	Annual registration, inspections
International	ISO 13485	QMS certification	Surveillance audits
Germany	MPG/MPDG	National implementation	Competent authority filings

Activity	QMR Role	Preparation Required
Notified Body audit	Primary contact	Audit package, personnel schedules
FDA inspection	Host, escort coordinator	Inspection readiness review
Competent Authority inquiry	Response coordinator	Technical file access
Regulatory meeting	Attendee or delegate	Briefing materials

Area	Ready	Action Needed
Document control system current	☐
Training records complete	☐
CAPA system current, no overdue items	☐
Complaint files complete	☐
Equipment calibration current	☐
Supplier qualification files complete	☐
Management review records available	☐
Internal audit program current	☐

Criteria	Weight	Score Method
Regulatory requirement	30%	Required=10, Recommended=5, Optional=2
Customer impact	25%	Direct=10, Indirect=5, None=0
Cost savings potential	20%	>$100K=10, $50-100K=7, <$50K=3
Implementation complexity	15%	Simple=10, Moderate=5, Complex=2
Strategic alignment	10%	Core=10, Supporting=5, Peripheral=2

Document	Content
management-review-guide.md	ISO 13485 Clause 5.6 requirements, input/output templates, action tracking
quality-kpi-framework.md	KPI categories, targets, calculations, dashboard templates

Resource Type	Allocation Authority	Escalation Threshold
Quality personnel	QMR	>1 FTE addition
Quality equipment	QMR	>$25K
External consultants	QMR	>$50K or >30 days
Quality systems	Executive approval	>$100K

Input	Source	Required
Feedback	Customer complaints, surveys	Yes
Audit results	Internal and external audits	Yes
Process performance	Process metrics	Yes
Product conformity	Inspection, NC data	Yes
CAPA status	CAPA system	Yes
Previous actions	Prior review records	Yes
Changes	Regulatory, organizational	Yes
Recommendations	All sources	Yes

Output	Documentation Required
Improvement to QMS and processes	Action items with owners
Improvement to product	Project initiation if needed
Resource needs	Resource plan updates

Skill	Integration Point
quality-manager-qms-iso13485	QMS process management
capa-officer	CAPA system oversight
qms-audit-expert	Internal audit program
quality-documentation-manager	Document control oversight

quality-manager-qmr

Source facts

Install options

Review the source files

More from this repository

Senior Quality Manager Responsible Person (QMR)

Table of Contents

QMR Responsibilities

ISO 13485 Clause 5.5.2 Requirements

QMR Accountability Matrix

More from this repository

Senior Quality Manager Responsible Person (QMR)

Table of Contents

QMR Responsibilities

ISO 13485 Clause 5.5.2 Requirements

QMR Accountability Matrix

Authority Boundaries

Management Review Workflow

Workflow: Prepare and Execute Management Review

Required Attendees

Management Review Input Template

Management Review Output Requirements

Quality KPI Management Workflow

Workflow: Establish Quality KPI Framework

Core Quality KPIs

KPI Review Frequency

Performance Response Matrix

Quality Objectives Workflow

Workflow: Annual Quality Objectives Setting

Quality Objective Structure

Objective Categories

Quarterly Objective Review

Quality Culture Assessment Workflow

Workflow: Annual Quality Culture Assessment

Quality Culture Dimensions

Culture Survey Categories

Culture Improvement Actions

Regulatory Compliance Oversight

Multi-Jurisdictional Compliance Matrix

Compliance Monitoring Workflow

Regulatory Authority Interface

Inspection Readiness Checklist

Decision Frameworks

Escalation Decision Tree

Quality Investment Prioritization

Resource Allocation Matrix

Tools and References

Scripts

References

Quick Reference: Management Review Inputs (ISO 13485 Clause 5.6.2)

Quick Reference: Management Review Outputs (ISO 13485 Clause 5.6.3)

Related Skills

Why This Skill Exists

When to Use

What If Fails