quality-manager-qmr

SKILL.md

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

Ensure comprehensive regulatory compliance across all applicable jurisdictions and standards.

Compliance Monitoring System:

Multi-jurisdictional Compliance Tracking

EU MDR 2017/745 compliance status monitoring

FDA QSR 21 CFR 820 compliance verification

ISO 13485 certification maintenance

National regulatory requirements adherence

Compliance Risk Assessment

Regulatory risk identification and assessment

Compliance gap analysis and remediation

Regulatory change impact evaluation

Decision Point: Escalate significant compliance risks to senior management

Regulatory Authority Interface

For EU Authorities: Coordinate with Notified Bodies and Competent Authorities

For FDA: Manage FDA communications and inspection readiness

For Other Markets: Oversee international regulatory compliance

Authority communication oversight and strategy

3. Management Review and Reporting (ISO 13485 Clause 5.6)

Lead management review processes ensuring systematic quality system evaluation and strategic quality planning.

Management Review Leadership:

Quarterly Management Reviews with C-level executives

Quality Performance Dashboards with real-time KPIs

Annual Quality Strategy Planning sessions

Regulatory Compliance Reports to board and senior management

Key Review Topics:

Quality management system performance and effectiveness

Regulatory compliance status and emerging requirements

Customer satisfaction trends and market feedback

Quality costs and return on quality investments

Strategic quality initiatives and resource requirements

4. Quality Culture and Leadership

Foster organizational quality culture ensuring quality excellence throughout the organization.

Quality Culture Initiatives:

Quality Leadership Development programs

Quality Awareness Training for all employees

Quality Recognition Programs and incentives

Quality Communication strategies and campaigns

Strategic Quality Management

Quality Strategic Planning

Develop and implement comprehensive quality strategies aligned with business objectives and regulatory requirements.

Strategic Planning Process:

Quality Strategy Development

Business objective alignment and integration

Regulatory landscape analysis and planning

Quality investment prioritization and ROI analysis

Competitive quality positioning assessment

Quality Resource Management

Quality team capability assessment and development

Quality technology and system modernization

Quality infrastructure investment planning

External quality resource utilization

Quality Performance Management

Quality KPI framework development and monitoring

Quality scorecards and dashboard implementation

Quality benchmarking and best practice identification

Quality improvement initiative prioritization

Cross-functional Quality Integration

Ensure quality considerations are integrated across all organizational functions and processes.

Quality Integration Framework:

R&D Integration: Design quality and design controls oversight

Manufacturing Integration: Production quality and process validation

Supply Chain Integration: Supplier quality and supply chain risk management

Commercial Integration: Customer quality and market quality feedback

Quality System Governance

Quality Policy and Objectives (ISO 13485 Clause 5.3 & 5.4.1)

Establish and maintain organizational quality policy and measurable quality objectives.

Quality Governance Structure:

Quality Policy: Top-level quality commitment and direction

Quality Objectives: Measurable quality targets and KPIs

Quality Planning: Strategic and operational quality planning

Quality Communication: Quality policy and objective communication

Document and Change Control Oversight

Ensure robust document control and change management processes throughout the organization.

Document Control Oversight:

Document control system effectiveness monitoring

Change control process compliance verification

Document review and approval process optimization

Configuration management and version control oversight

Quality Audit Program Oversight

Provide strategic oversight of internal and external audit programs ensuring comprehensive quality system assessment.

Audit Program Management:

Internal Audit Program: Strategic audit planning and resource allocation

External Audit Coordination: Regulatory and certification body audit management

Audit Follow-up Oversight: Corrective action effectiveness verification

Audit Performance Assessment: Audit program effectiveness evaluation

Regulatory Interface Management

Regulatory Authority Relationships

Maintain strategic relationships with regulatory authorities ensuring effective communication and collaboration.

Authority Relationship Management:

Regulatory Authority Meetings: Strategic regulatory discussions and planning

Regulatory Submission Oversight: Quality and completeness verification

Regulatory Inspection Management: Preparation, coordination, and follow-up

Regulatory Intelligence: Authority position monitoring and trend analysis

Quality System Certification Management

Oversee all quality system certifications ensuring compliance and continuous improvement.

Certification Management:

ISO 13485 Certification: Maintenance and continuous improvement

Regulatory Certifications: FDA registration, CE marking, other market certifications

Quality Certifications: Additional quality certifications and accreditations

Certification Strategy: Multi-market certification planning and optimization

Quality Performance Monitoring

Quality Key Performance Indicators (KPIs)

Monitor comprehensive quality performance metrics ensuring quality excellence and regulatory compliance.

Quality Performance Dashboard:

Quality System Effectiveness: Process performance, audit results, nonconformity trends

Customer Quality: Customer satisfaction, complaint rates, return rates

Product Quality: Product conformity, defect rates, quality costs

Regulatory Compliance: Compliance scores, submission success rates, inspection outcomes

Quality Culture: Training completion, quality awareness, employee engagement

Quality Cost Management

Monitor and optimize quality costs ensuring cost-effective quality management.

Quality Cost Categories:

Prevention Costs: Quality planning, training, prevention activities

Appraisal Costs: Inspection, testing, audit activities

Internal Failure Costs: Rework, scrap, internal quality failures

External Failure Costs: Returns, recalls, customer complaints, regulatory sanctions

Resources

scripts/

qmr-dashboard.py: Comprehensive QMR performance monitoring and reporting

regulatory-compliance-tracker.py: Multi-jurisdictional compliance status monitoring

quality-cost-analyzer.py: Quality cost analysis and optimization tool

management-review-automation.py: Management review preparation and follow-up automation

references/

qmr-responsibilities-matrix.md: Comprehensive QMR responsibility framework

regulatory-compliance-requirements.md: Multi-jurisdictional regulatory requirement library

quality-strategic-planning-guide.md: Quality strategy development methodologies

quality-culture-development.md: Quality culture assessment and development frameworks

quality-kpi-library.md: Comprehensive quality performance indicator definitions

assets/

qmr-templates/: QMR reporting templates, quality policy templates, strategic planning tools

compliance-dashboards/: Regulatory compliance monitoring dashboards

quality-communication/: Quality communication templates and presentation materials

training-materials/: QMR and quality leadership training programs