Senior Quality Manager Responsible Person (QMR) | Skills Pool
Senior Quality Manager Responsible Person (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, management responsibility, and quality strategic planning.
Mishit18 1 星标 2026年4月11日
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
快速安装
Senior Quality Manager Responsible Person (QMR) npx skillvault add Mishit18/mishit18-claude-code-templates-cli-tool-components-skills-enterprise-communication-quality-manager-qmr-skill-md
作者 Mishit18
星标 1
更新时间 2026年4月11日
职业
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 monitoringFDA QSR 21 CFR 820 compliance verificationISO 13485 certification maintenanceNational 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 AuthoritiesFor FDA : Manage FDA communications and inspection readinessFor Other Markets : Oversee international regulatory complianceAuthority 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 executivesQuality Performance Dashboards with real-time KPIsAnnual Quality Strategy Planning sessionsRegulatory Compliance Reports to board and senior management
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 programsQuality Awareness Training for all employeesQuality Recognition Programs and incentivesQuality 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 oversightManufacturing Integration : Production quality and process validationSupply Chain Integration : Supplier quality and supply chain risk managementCommercial 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 directionQuality Objectives : Measurable quality targets and KPIsQuality Planning : Strategic and operational quality planningQuality 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 allocationExternal Audit Coordination : Regulatory and certification body audit managementAudit Follow-up Oversight : Corrective action effectiveness verificationAudit 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 planningRegulatory Submission Oversight : Quality and completeness verificationRegulatory Inspection Management : Preparation, coordination, and follow-upRegulatory 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 improvementRegulatory Certifications : FDA registration, CE marking, other market certificationsQuality Certifications : Additional quality certifications and accreditationsCertification Strategy : Multi-market certification planning and optimization
Monitor comprehensive quality performance metrics ensuring quality excellence and regulatory compliance.
Quality Performance Dashboard:
Quality System Effectiveness : Process performance, audit results, nonconformity trendsCustomer Quality : Customer satisfaction, complaint rates, return ratesProduct Quality : Product conformity, defect rates, quality costsRegulatory Compliance : Compliance scores, submission success rates, inspection outcomesQuality Culture : Training completion, quality awareness, employee engagement
Quality Cost Management Monitor and optimize quality costs ensuring cost-effective quality management.
Prevention Costs : Quality planning, training, prevention activitiesAppraisal Costs : Inspection, testing, audit activitiesInternal Failure Costs : Rework, scrap, internal quality failuresExternal Failure Costs : Returns, recalls, customer complaints, regulatory sanctions
Resources
scripts/
qmr-dashboard.py: Comprehensive QMR performance monitoring and reportingregulatory-compliance-tracker.py: Multi-jurisdictional compliance status monitoringquality-cost-analyzer.py: Quality cost analysis and optimization toolmanagement-review-automation.py: Management review preparation and follow-up automation
references/
qmr-responsibilities-matrix.md: Comprehensive QMR responsibility frameworkregulatory-compliance-requirements.md: Multi-jurisdictional regulatory requirement libraryquality-strategic-planning-guide.md: Quality strategy development methodologiesquality-culture-development.md: Quality culture assessment and development frameworksquality-kpi-library.md: Comprehensive quality performance indicator definitions
assets/
qmr-templates/: QMR reporting templates, quality policy templates, strategic planning toolscompliance-dashboards/: Regulatory compliance monitoring dashboardsquality-communication/: Quality communication templates and presentation materialstraining-materials/: QMR and quality leadership training programs 02
1. Overall Quality System Responsibility (ISO 13485 Clause 5.5.2)
销售与营销
Open a Pull Request Open a pull request with proper PR template, test coverage, and review workflow. Guides agents through creating a PR that follows repo conventions, ensures existing behaviors aren't broken, covers new behaviors with tests, and handles review via bot when local testing isn't possible. TRIGGER when user asks to "open a PR", "create a PR", "make a PR", "submit a PR", "open pull request", "push and create PR", or any variation of opening/submitting a pull request.
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