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Use when setting up pipelines, deploying applications, managing infrastructure, implementing monitoring, or optimizing deployment processes.","afaizalam2003\u002FMaster-claude-skill","afaizalam2003","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F222019359?v=4","01M6K8F2XNT0HKBPF00JQ78SV3","Faiz Alam","01M6K8F31EBXAPER0EG8R9HTR5",3,"MIT","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fengineering-team\u002Fsenior-devops\u002FSKILL.md",[18,23,26],{"categoryNo":19,"categoryName":20,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000011","运维与部署","SCENARIO","使用场景",{"categoryNo":24,"categoryName":25,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000023","Skill与智能体开发",{"categoryNo":27,"categoryName":28,"taxonomyType":29,"taxonomyTypeDesc":30},"01JBSEEDCAT000000000000030","开发工程师","PROFESSION","适用职业",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"devops","senior devops","for","automation","implementing","CI\u002FCD","as","containerization","up","use","applications","pipeline","gcp","ci","monitoring","infrastructure as code","code","deployment","infrastructure","azure","2026-11-10 10:12:30",false,"---\nname: \"senior-devops\"\ndescription: Comprehensive DevOps skill for CI\u002FCD, infrastructure automation, containerization, and cloud platforms (AWS, GCP, Azure). Includes pipeline setup, infrastructure as code, deployment automation, and monitoring. Use when setting up pipelines, deploying applications, managing infrastructure, implementing monitoring, or optimizing deployment processes.\n---\n\n# Senior Devops\n\nComplete toolkit for senior devops with modern tools and best practices.\n\n## Quick Start\n\n### Main Capabilities\n\nThis skill provides three core capabilities through automated scripts:\n\n```bash\n# Script 1: Pipeline Generator — scaffolds CI\u002FCD pipelines for GitHub Actions or CircleCI\npython scripts\u002Fpipeline_generator.py .\u002Fapp --platform=github --stages=build,test,deploy\n\n# Script 2: Terraform Scaffolder — generates and validates IaC modules for AWS\u002FGCP\u002FAzure\npython scripts\u002Fterraform_scaffolder.py .\u002Finfra --provider=aws --module=ecs-service --verbose\n\n# Script 3: Deployment Manager — orchestrates container deployments with rollback support\npython3 scripts\u002Fdeployment_manager.py .\u002Fdeploy --verbose --json\n```\n\n## Core Capabilities\n\n### 1. Pipeline Generator\n\nScaffolds CI\u002FCD pipeline configurations for GitHub Actions or CircleCI, with stages for build, test, security scan, and deploy.\n\n**Example — GitHub Actions workflow:**\n```yaml\n# .github\u002Fworkflows\u002Fci.yml\nname: CI\u002FCD Pipeline\non:\n  push:\n    branches: [main, develop]\n  pull_request:\n    branches: [main]\n\njobs:\n  build-and-test:\n    runs-on: ubuntu-latest\n    steps:\n      - uses: actions\u002Fcheckout@v4\n      - name: Set up Node.js\n        uses: actions\u002Fsetup-node@v4\n        with:\n          node-version: '20'\n          cache: 'npm'\n      - run: npm ci\n      - run: npm run lint\n      - run: npm test -- --coverage\n      - name: Upload coverage\n        uses: codecov\u002Fcodecov-action@v4\n\n  build-docker:\n    needs: build-and-test\n    runs-on: ubuntu-latest\n    steps:\n      - uses: actions\u002Fcheckout@v4\n      - name: Build and push image\n        uses: docker\u002Fbuild-push-action@v5\n        with:\n          push: ${{ github.ref == 'refs\u002Fheads\u002Fmain' }}\n          tags: ghcr.io\u002F${{ github.repository }}:${{ github.sha }}\n\n  deploy:\n    needs: build-docker\n    if: github.ref == 'refs\u002Fheads\u002Fmain'\n    runs-on: ubuntu-latest\n    steps:\n      - name: Deploy to ECS\n        run: |\n          aws ecs update-service \\\n            --cluster production \\\n            --service app-service \\\n            --force-new-deployment\n```\n\n**Usage:**\n```bash\npython scripts\u002Fpipeline_generator.py \u003Cproject-path> --platform=github|circleci --stages=build,test,deploy\n```\n\n### 2. Terraform Scaffolder\n\nGenerates, validates, and plans Terraform modules. Enforces consistent module structure and runs `terraform validate` + `terraform plan` before any apply.\n\n**Example — AWS ECS service module:**\n```hcl\n# modules\u002Fecs-service\u002Fmain.tf\nresource \"aws_ecs_task_definition\" \"app\" {\n  family                   = var.service_name\n  requires_compatibilities = [\"FARGATE\"]\n  network_mode             = \"awsvpc\"\n  cpu                      = var.cpu\n  memory                   = var.memory\n\n  container_definitions = jsonencode([{\n    name      = var.service_name\n    image     = var.container_image\n    essential = true\n    portMappings = [{\n      containerPort = var.container_port\n      protocol      = \"tcp\"\n    }]\n    environment = [for k, v in var.env_vars : { name = k, value = v }]\n    logConfiguration = {\n      logDriver = \"awslogs\"\n      options = {\n        awslogs-group         = \"\u002Fecs\u002F${var.service_name}\"\n        awslogs-region        = var.aws_region\n        awslogs-stream-prefix = \"ecs\"\n      }\n    }\n  }])\n}\n\nresource \"aws_ecs_service\" \"app\" {\n  name            = var.service_name\n  cluster         = var.cluster_id\n  task_definition = aws_ecs_task_definition.app.arn\n  desired_count   = var.desired_count\n  launch_type     = \"FARGATE\"\n\n  network_configuration {\n    subnets          = var.private_subnet_ids\n    security_groups  = [aws_security_group.app.id]\n    assign_public_ip = false\n  }\n\n  load_balancer {\n    target_group_arn = aws_lb_target_group.app.arn\n    container_name   = var.service_name\n    container_port   = var.container_port\n  }\n}\n```\n\n**Usage:**\n```bash\npython scripts\u002Fterraform_scaffolder.py \u003Ctarget-path> --provider=aws|gcp|azure --module=ecs-service|gke-deployment|aks-service [--verbose]\n```\n\n### 3. Deployment Manager\n\nOrchestrates deployments with blue\u002Fgreen or rolling strategies, health-check gates, and automatic rollback on failure.\n\n**Example — Kubernetes blue\u002Fgreen deployment (blue-slot specific elements):**\n```yaml\n# k8s\u002Fdeployment-blue.yaml\napiVersion: apps\u002Fv1\nkind: Deployment\nmetadata:\n  name: app-blue\n  labels:\n    app: myapp\n    slot: blue      # slot label distinguishes blue from green\nspec:\n  replicas: 3\n  selector:\n    matchLabels:\n      app: myapp\n      slot: blue\n  template:\n    metadata:\n      labels:\n        app: myapp\n        slot: blue\n    spec:\n      containers:\n        - name: app\n          image: ghcr.io\u002Forg\u002Fapp:1.2.3\n          readinessProbe:       # gate: pod must pass before traffic switches\n            httpGet:\n              path: \u002Fhealthz\n              port: 8080\n            initialDelaySeconds: 10\n            periodSeconds: 5\n          resources:\n            requests:\n              cpu: \"250m\"\n              memory: \"256Mi\"\n            limits:\n              cpu: \"500m\"\n              memory: \"512Mi\"\n```\n\n**Usage:**\n```bash\npython scripts\u002Fdeployment_manager.py deploy \\\n  --env=staging|production \\\n  --image=app:1.2.3 \\\n  --strategy=blue-green|rolling \\\n  --health-check-url=https:\u002F\u002Fapp.example.com\u002Fhealthz\n\npython scripts\u002Fdeployment_manager.py rollback --env=production --to-version=1.2.2\npython scripts\u002Fdeployment_manager.py --analyze --env=production   # audit current state\n```\n\n## Resources\n\n- Pattern Reference: `references\u002Fcicd_pipeline_guide.md` — detailed CI\u002FCD patterns, best practices, anti-patterns\n- Workflow Guide: `references\u002Finfrastructure_as_code.md` — IaC step-by-step processes, optimization, troubleshooting\n- Technical Guide: `references\u002Fdeployment_strategies.md` — deployment strategy configs, security considerations, scalability\n- Tool Scripts: `scripts\u002F` directory\n\n## Development Workflow\n\n### 1. Infrastructure Changes (Terraform)\n\n```bash\n# Scaffold or update module\npython scripts\u002Fterraform_scaffolder.py .\u002Finfra --provider=aws --module=ecs-service --verbose\n\n# Validate and plan — review diff before applying\nterraform -chdir=infra init\nterraform -chdir=infra validate\nterraform -chdir=infra plan -out=tfplan\n\n# Apply only after plan review\nterraform -chdir=infra apply tfplan\n\n# Verify resources are healthy\naws ecs describe-services --cluster production --services app-service \\\n  --query 'services[0].{Status:status,Running:runningCount,Desired:desiredCount}'\n```\n\n### 2. Application Deployment\n\n```bash\n# Generate or update pipeline config\npython scripts\u002Fpipeline_generator.py . --platform=github --stages=build,test,security,deploy\n\n# Build and tag image\ndocker build -t ghcr.io\u002Forg\u002Fapp:$(git rev-parse --short HEAD) .\ndocker push ghcr.io\u002Forg\u002Fapp:$(git rev-parse --short HEAD)\n\n# Deploy with health-check gate\npython scripts\u002Fdeployment_manager.py deploy \\\n  --env=production \\\n  --image=app:$(git rev-parse --short HEAD) \\\n  --strategy=blue-green \\\n  --health-check-url=https:\u002F\u002Fapp.example.com\u002Fhealthz\n\n# Verify pods are running\nkubectl get pods -n production -l app=myapp\nkubectl rollout status deployment\u002Fapp-blue -n production\n\n# Switch traffic after verification\nkubectl patch service app-svc -n production \\\n  -p '{\"spec\":{\"selector\":{\"slot\":\"blue\"}}}'\n```\n\n### 3. Rollback Procedure\n\n```bash\n# Immediate rollback via deployment manager\npython scripts\u002Fdeployment_manager.py rollback --env=production --to-version=1.2.2\n\n# Or via kubectl\nkubectl rollout undo deployment\u002Fapp -n production\nkubectl rollout status deployment\u002Fapp -n production\n\n# Verify rollback succeeded\nkubectl get pods -n production -l app=myapp\ncurl -sf https:\u002F\u002Fapp.example.com\u002Fhealthz || echo \"ROLLBACK FAILED — escalate\"\n```\n\n## Multi-Cloud Cross-References\n\nUse these companion skills for cloud-specific deep dives:\n\n| Skill | Cloud | Use When |\n|-------|-------|----------|\n| **aws-solution-architect** | AWS | ECS\u002FEKS, Lambda, VPC design, cost optimization |\n| **azure-cloud-architect** | Azure | AKS, App Service, Virtual Networks, Azure DevOps |\n| **gcp-cloud-architect** | GCP | GKE, Cloud Run, VPC, Cloud Build *(coming soon)* |\n\n**Multi-cloud vs single-cloud decision:**\n- **Single-cloud** (default) — lower operational complexity, deeper managed-service integration, better cost leverage with committed-use discounts\n- **Multi-cloud** — required when mandated by compliance\u002Fdata residency, acquiring companies on different clouds, or needing best-of-breed services across providers (e.g., AWS for compute + GCP for ML)\n- **Hybrid** — on-prem + cloud; use when regulated workloads must stay on-prem while burst\u002Fnon-sensitive workloads run in the cloud\n\n> Start single-cloud. Add a second cloud only when there is a concrete business or compliance driver — not for theoretical redundancy.\n\n---\n\n## Cloud-Agnostic IaC\n\n### Terraform \u002F OpenTofu (Default Choice)\n\nTerraform (or its open-source fork OpenTofu) is the recommended IaC tool for most teams:\n- Single language (HCL) across AWS, Azure, GCP, and 3,000+ providers\n- State management with remote backends (S3, GCS, Azure Blob)\n- Plan-before-apply workflow prevents drift surprises\n- Cross-reference **terraform-patterns** for module structure, state isolation, and CI\u002FCD integration\n\n### Pulumi (Programming Language IaC)\n\nChoose Pulumi when the team strongly prefers TypeScript, Python, Go, or C# over HCL:\n- Full programming language — loops, conditionals, unit tests native\n- Same cloud provider coverage as Terraform\n- Easier onboarding for dev teams that resist learning HCL\n\n### When to Use Cloud-Native IaC\n\n| Tool | Use When |\n|------|----------|\n| **CloudFormation** | AWS-only shop; need native AWS support (StackSets, Service Catalog) |\n| **Bicep** | Azure-only shop; simpler syntax than ARM templates |\n| **Cloud Deployment Manager** | GCP-only; rare — most GCP teams prefer Terraform |\n\n> **Rule of thumb:** Use Terraform\u002FOpenTofu unless you are 100% committed to a single cloud AND the cloud-native tool offers a feature Terraform cannot replicate (e.g., AWS Service Catalog integration).\n\n---\n\n## Troubleshooting\n\nCheck the comprehensive troubleshooting section in `references\u002Fdeployment_strategies.md`.\n","# Senior Devops\n\nComplete toolkit for senior devops with modern tools and best practices.\n\n## Quick Start\n\n### Main Capabilities\n\nThis skill provides three core capabilities through automated scripts:\n\n```bash\n# Script 1: Pipeline Generator — scaffolds CI\u002FCD pipelines for GitHub Actions or CircleCI\npython scripts\u002Fpipeline_generator.py .\u002Fapp --platform=github --stages=build,test,deploy\n\n# Script 2: Terraform Scaffolder — generates and validates IaC modules for AWS\u002FGCP\u002FAzure\npython scripts\u002Fterraform_scaffolder.py .\u002Finfra --provider=aws --module=ecs-service --verbose\n\n# Script 3: Deployment Manager — orchestrates container deployments with rollback support\npython3 scripts\u002Fdeployment_manager.py .\u002Fdeploy --verbose --json\n```\n\n## Core Capabilities\n\n### 1. Pipeline Generator\n\nScaffolds CI\u002FCD pipeline configurations for GitHub Actions or CircleCI, with stages for build, test, security scan, and deploy.\n\n**Example — GitHub Actions workflow:**\n```yaml\n# .github\u002Fworkflows\u002Fci.yml\nname: CI\u002FCD Pipeline\non:\n  push:\n    branches: [main, develop]\n  pull_request:\n    branches: [main]\n\njobs:\n  build-and-test:\n    runs-on: ubuntu-latest\n    steps:\n      - uses: actions\u002Fcheckout@v4\n      - name: Set up Node.js\n        uses: actions\u002Fsetup-node@v4\n        with:\n          node-version: '20'\n          cache: 'npm'\n      - run: npm ci\n      - run: npm run lint\n      - run: npm test -- --coverage\n      - name: Upload coverage\n        uses: codecov\u002Fcodecov-action@v4\n\n  build-docker:\n    needs: build-and-test\n    runs-on: ubuntu-latest\n    steps:\n      - uses: actions\u002Fcheckout@v4\n      - name: Build and push image\n        uses: docker\u002Fbuild-push-action@v5\n        with:\n          push: ${{ github.ref == 'refs\u002Fheads\u002Fmain' }}\n          tags: ghcr.io\u002F${{ github.repository }}:${{ github.sha }}\n\n  deploy:\n    needs: build-docker\n    if: github.ref == 'refs\u002Fheads\u002Fmain'\n    runs-on: ubuntu-latest\n    steps:\n      - name: Deploy to ECS\n        run: |\n          aws ecs update-service \\\n            --cluster production \\\n            --service app-service \\\n            --force-new-deployment\n```\n\n**Usage:**\n```bash\npython scripts\u002Fpipeline_generator.py \u003Cproject-path> --platform=github|circleci --stages=build,test,deploy\n```\n\n### 2. Terraform Scaffolder\n\nGenerates, validates, and plans Terraform modules. Enforces consistent module structure and runs `terraform validate` + `terraform plan` before any apply.\n\n**Example — AWS ECS service module:**\n```hcl\n# modules\u002Fecs-service\u002Fmain.tf\nresource \"aws_ecs_task_definition\" \"app\" {\n  family                   = var.service_name\n  requires_compatibilities = [\"FARGATE\"]\n  network_mode             = \"awsvpc\"\n  cpu                      = var.cpu\n  memory                   = var.memory\n\n  container_definitions = jsonencode([{\n    name      = var.service_name\n    image     = var.container_image\n    essential = true\n    portMappings = [{\n      containerPort = var.container_port\n      protocol      = \"tcp\"\n    }]\n    environment = [for k, v in var.env_vars : { name = k, value = v }]\n    logConfiguration = {\n      logDriver = \"awslogs\"\n      options = {\n        awslogs-group         = \"\u002Fecs\u002F${var.service_name}\"\n        awslogs-region        = var.aws_region\n        awslogs-stream-prefix = \"ecs\"\n      }\n    }\n  }])\n}\n\nresource \"aws_ecs_service\" \"app\" {\n  name            = var.service_name\n  cluster         = var.cluster_id\n  task_definition = aws_ecs_task_definition.app.arn\n  desired_count   = var.desired_count\n  launch_type     = \"FARGATE\"\n\n  network_configuration {\n    subnets          = var.private_subnet_ids\n    security_groups  = [aws_security_group.app.id]\n    assign_public_ip = false\n  }\n\n  load_balancer {\n    target_group_arn = aws_lb_target_group.app.arn\n    container_name   = var.service_name\n    container_port   = var.container_port\n  }\n}\n```\n\n**Usage:**\n```bash\npython scripts\u002Fterraform_scaffolder.py \u003Ctarget-path> --provider=aws|gcp|azure --module=ecs-service|gke-deployment|aks-service [--verbose]\n```\n\n### 3. Deployment Manager\n\nOrchestrates deployments with blue\u002Fgreen or rolling strategies, health-check gates, and automatic rollback on failure.\n\n**Example — Kubernetes blue\u002Fgreen deployment (blue-slot specific elements):**\n```yaml\n# k8s\u002Fdeployment-blue.yaml\napiVersion: apps\u002Fv1\nkind: Deployment\nmetadata:\n  name: app-blue\n  labels:\n    app: myapp\n    slot: blue      # slot label distinguishes blue from green\nspec:\n  replicas: 3\n  selector:\n    matchLabels:\n      app: myapp\n      slot: blue\n  template:\n    metadata:\n      labels:\n        app: myapp\n        slot: blue\n    spec:\n      containers:\n        - name: app\n          image: ghcr.io\u002Forg\u002Fapp:1.2.3\n          readinessProbe:       # gate: pod must pass before traffic switches\n            httpGet:\n              path: \u002Fhealthz\n              port: 8080\n            initialDelaySeconds: 10\n            periodSeconds: 5\n          resources:\n            requests:\n              cpu: \"250m\"\n              memory: \"256Mi\"\n            limits:\n              cpu: \"500m\"\n              memory: \"512Mi\"\n```\n\n**Usage:**\n```bash\npython scripts\u002Fdeployment_manager.py deploy \\\n  --env=staging|production \\\n  --image=app:1.2.3 \\\n  --strategy=blue-green|rolling \\\n  --health-check-url=https:\u002F\u002Fapp.example.com\u002Fhealthz\n\npython scripts\u002Fdeployment_manager.py rollback --env=production --to-version=1.2.2\npython scripts\u002Fdeployment_manager.py --analyze --env=production   # audit current state\n```\n\n## Resources\n\n- Pattern Reference: `references\u002Fcicd_pipeline_guide.md` — detailed CI\u002FCD patterns, best practices, anti-patterns\n- Workflow Guide: `references\u002Finfrastructure_as_code.md` — IaC step-by-step processes, optimization, troubleshooting\n- Technical Guide: `references\u002Fdeployment_strategies.md` — deployment strategy configs, security considerations, scalability\n- Tool Scripts: `scripts\u002F` directory\n\n## Development Workflow\n\n### 1. Infrastructure Changes (Terraform)\n\n```bash\n# Scaffold or update module\npython scripts\u002Fterraform_scaffolder.py .\u002Finfra --provider=aws --module=ecs-service --verbose\n\n# Validate and plan — review diff before applying\nterraform -chdir=infra init\nterraform -chdir=infra validate\nterraform -chdir=infra plan -out=tfplan\n\n# Apply only after plan review\nterraform -chdir=infra apply tfplan\n\n# Verify resources are healthy\naws ecs describe-services --cluster production --services app-service \\\n  --query 'services[0].{Status:status,Running:runningCount,Desired:desiredCount}'\n```\n\n### 2. Application Deployment\n\n```bash\n# Generate or update pipeline config\npython scripts\u002Fpipeline_generator.py . --platform=github --stages=build,test,security,deploy\n\n# Build and tag image\ndocker build -t ghcr.io\u002Forg\u002Fapp:$(git rev-parse --short HEAD) .\ndocker push ghcr.io\u002Forg\u002Fapp:$(git rev-parse --short HEAD)\n\n# Deploy with health-check gate\npython scripts\u002Fdeployment_manager.py deploy \\\n  --env=production \\\n  --image=app:$(git rev-parse --short HEAD) \\\n  --strategy=blue-green \\\n  --health-check-url=https:\u002F\u002Fapp.example.com\u002Fhealthz\n\n# Verify pods are running\nkubectl get pods -n production -l app=myapp\nkubectl rollout status deployment\u002Fapp-blue -n production\n\n# Switch traffic after verification\nkubectl patch service app-svc -n production \\\n  -p '{\"spec\":{\"selector\":{\"slot\":\"blue\"}}}'\n```\n\n### 3. Rollback Procedure\n\n```bash\n# Immediate rollback via deployment manager\npython scripts\u002Fdeployment_manager.py rollback --env=production --to-version=1.2.2\n\n# Or via kubectl\nkubectl rollout undo deployment\u002Fapp -n production\nkubectl rollout status deployment\u002Fapp -n production\n\n# Verify rollback succeeded\nkubectl get pods -n production -l app=myapp\ncurl -sf https:\u002F\u002Fapp.example.com\u002Fhealthz || echo \"ROLLBACK FAILED — escalate\"\n```\n\n## Multi-Cloud Cross-References\n\nUse these companion skills for cloud-specific deep dives:\n\n| Skill | Cloud | Use When |\n|-------|-------|----------|\n| **aws-solution-architect** | AWS | ECS\u002FEKS, Lambda, VPC design, cost optimization |\n| **azure-cloud-architect** | Azure | AKS, App Service, Virtual Networks, Azure DevOps |\n| **gcp-cloud-architect** | GCP | GKE, Cloud Run, VPC, Cloud Build *(coming soon)* |\n\n**Multi-cloud vs single-cloud decision:**\n- **Single-cloud** (default) — lower operational complexity, deeper managed-service integration, better cost leverage with committed-use discounts\n- **Multi-cloud** — required when mandated by compliance\u002Fdata residency, acquiring companies on different clouds, or needing best-of-breed services across providers (e.g., AWS for compute + GCP for ML)\n- **Hybrid** — on-prem + cloud; use when regulated workloads must stay on-prem while burst\u002Fnon-sensitive workloads run in the cloud\n\n> Start single-cloud. Add a second cloud only when there is a concrete business or compliance driver — not for theoretical redundancy.\n\n---\n\n## Cloud-Agnostic IaC\n\n### Terraform \u002F OpenTofu (Default Choice)\n\nTerraform (or its open-source fork OpenTofu) is the recommended IaC tool for most teams:\n- Single language (HCL) across AWS, Azure, GCP, and 3,000+ providers\n- State management with remote backends (S3, GCS, Azure Blob)\n- Plan-before-apply workflow prevents drift surprises\n- Cross-reference **terraform-patterns** for module structure, state isolation, and CI\u002FCD integration\n\n### Pulumi (Programming Language IaC)\n\nChoose Pulumi when the team strongly prefers TypeScript, Python, Go, or C# over HCL:\n- Full programming language — loops, conditionals, unit tests native\n- Same cloud provider coverage as Terraform\n- Easier onboarding for dev teams that resist learning HCL\n\n### When to Use Cloud-Native IaC\n\n| Tool | Use When |\n|------|----------|\n| **CloudFormation** | AWS-only shop; 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Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Frisk-management-specialist\u002FSKILL.md",[],[142,143,144,145,146,147,148,149,124,41,150,151,152,153,154,155,156,157,158,36],"risk","risk management specialist","management","risk management","risk evaluation","product","Evaluation","lifecycle","risk matrix","iso","medical","iso 14971","identification","information","post-production","tree","matrix",{"skillNo":160,"name":161,"nameZh":6,"description":162,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":163,"categories":164,"keywords":165,"publishedAt":52},"01M6KC3HF5ZFSSP2NZF68PEPFB","regulatory-affairs-head","Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017\u002F745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md",[],[166,167,168,169,170,171,172,173,174,41,175,176,177,178,179,180,181,182,183,34],"regulatory affairs head","regulatory","head","documents","devices","health","plan","write","strategy","standards","queries","manage","strategies","de","users","respond","medical devices","manager",{"skillNo":185,"name":186,"nameZh":6,"description":187,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":188,"categories":189,"keywords":196,"publishedAt":52},"01M6KC34Z8M1559EY1CXYBJB1A","quality-manager-qms-iso13485","ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qms-iso13485\u002FSKILL.md",[190,193],{"categoryNo":191,"categoryName":192,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000015","视觉设计",{"categoryNo":194,"categoryName":195,"taxonomyType":29,"taxonomyTypeDesc":30},"01JBSEEDCAT000000000000032","设计师",[197,198,183,199,200,201,202,203,204,41,205,206,207,208,209,210,211,212,34,213],"quality manager qms iso13485","quality","design","workflows","validation","actions","certification","system","maintenance","document","systems","records","ISO 13485","organizations","corrective action","internal audit","preparation",{"skillNo":215,"name":216,"nameZh":6,"description":217,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":218,"categories":219,"keywords":221,"publishedAt":52},"01M6KC2FXHBHXYX2ZZ17Y3GDB4","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.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qmr\u002FSKILL.md",[220],{"categoryNo":114,"categoryName":115,"taxonomyType":29,"taxonomyTypeDesc":30},[222,198,183,223,224,225,226,46,117,227,204,228,167,229,230,231,151,209,34,232],"quality manager qmr","review","policy","performance","governance","regulatory compliance","oversight","cost","culture","leadership","person",{"skillNo":234,"name":235,"nameZh":6,"description":236,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":12,"repositoryNo":13,"starsCount":14,"licenseSpdxId":15,"licenseFileUrl":6,"sourceHtmlUrl":237,"categories":238,"keywords":244,"publishedAt":52},"01M6KC1VRR5JTDBNZANHPS6VR6","quality-documentation-manager","Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.","https:\u002F\u002Fgithub.com\u002Fafaizalam2003\u002FMaster-claude-skill\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-documentation-manager\u002FSKILL.md",[239,242,243],{"categoryNo":240,"categoryName":241,"taxonomyType":21,"taxonomyTypeDesc":22},"01JBSEEDCAT000000000000002","文档处理",{"categoryNo":24,"categoryName":25,"taxonomyType":21,"taxonomyTypeDesc":22},{"categoryNo":114,"categoryName":115,"taxonomyType":29,"taxonomyTypeDesc":30},[245,246,198,183,223,247,248,121,204,249,250,251,252,253,152,254,255,256,257,34],"documentation","quality documentation manager","workflow","change","change management","list","master","system management","documentation review","cfr","21 cfr part 11","change control","retention"]