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Use for Jira project setup, configuration, advanced search, dashboard creation, workflow design, and technical Jira operations.","ArogyaReddy\u002Falirezarezvani-claude-skills","ArogyaReddy","https:\u002F\u002Favatars.githubusercontent.com\u002Fu\u002F12032101?v=4","01M6EJA7DAM8950XYAD875F4NY","01M6EJA7JSMD9SN617EJHTF2BQ",39,"MIT","https:\u002F\u002Fgithub.com\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fproject-management\u002Fjira-expert\u002FSKILL.md",[17,22],{"categoryNo":18,"categoryName":19,"taxonomyType":20,"taxonomyTypeDesc":21},"01JBSEEDCAT000000000000015","视觉设计","SCENARIO","使用场景",{"categoryNo":23,"categoryName":24,"taxonomyType":20,"taxonomyTypeDesc":21},"01JBSEEDCAT000000000000023","Skill与智能体开发",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"expert","jira","jira expert","projects","jql","creation","project","queries","use","product discovery","technical","design","discovery","search","product","planning","workflows","automation","dashboard","workflow","2026-11-10 10:12:30",false,"---\nname: \"jira-expert\"\ndescription: Atlassian Jira expert for creating and managing projects, planning, product discovery, JQL queries, workflows, custom fields, automation, reporting, and all Jira features. Use for Jira project setup, configuration, advanced search, dashboard creation, workflow design, and technical Jira operations.\n---\n\n# Atlassian Jira Expert\n\nMaster-level expertise in Jira configuration, project management, JQL, workflows, automation, and reporting. Handles all technical and operational aspects of Jira.\n\n## Quick Start — Most Common Operations\n\n**Create a project**:\n```\nmcp jira create_project --name \"My Project\" --key \"MYPROJ\" --type scrum --lead \"user@example.com\"\n```\n\n**Run a JQL query**:\n```\nmcp jira search_issues --jql \"project = MYPROJ AND status != Done AND dueDate \u003C now()\" --maxResults 50\n```\n\nFor full command reference, see [Atlassian MCP Integration](#atlassian-mcp-integration). For JQL functions, see [JQL Functions Reference](#jql-functions-reference). For report templates, see [Reporting Templates](#reporting-templates).\n\n---\n\n## Workflows\n\n### Project Creation\n1. Determine project type (Scrum, Kanban, Bug Tracking, etc.)\n2. Create project with appropriate template\n3. Configure project settings:\n   - Name, key, description\n   - Project lead and default assignee\n   - Notification scheme\n   - Permission scheme\n4. Set up issue types and workflows\n5. Configure custom fields if needed\n6. Create initial board\u002Fbacklog view\n7. **HANDOFF TO**: Scrum Master for team onboarding\n\n### Workflow Design\n1. Map out process states (To Do → In Progress → Done)\n2. Define transitions and conditions\n3. Add validators, post-functions, and conditions\n4. Configure workflow scheme\n5. **Validate**: Deploy to a test project first; verify all transitions, conditions, and post-functions behave as expected before associating with production projects\n6. Associate workflow with project\n7. Test workflow with sample issues\n\n### JQL Query Building\n**Basic Structure**: `field operator value`\n\n**Common Operators**:\n- `=, !=` : equals, not equals\n- `~, !~` : contains, not contains\n- `>, \u003C, >=, \u003C=` : comparison\n- `in, not in` : list membership\n- `is empty, is not empty`\n- `was, was in, was not`\n- `changed`\n\n**Powerful JQL Examples**:\n\nFind overdue issues:\n```jql\ndueDate \u003C now() AND status != Done\n```\n\nSprint burndown issues:\n```jql\nsprint = 23 AND status changed TO \"Done\" DURING (startOfSprint(), endOfSprint())\n```\n\nFind stale issues:\n```jql\nupdated \u003C -30d AND status != Done\n```\n\nCross-project epic tracking:\n```jql\n\"Epic Link\" = PROJ-123 ORDER BY rank\n```\n\nVelocity calculation:\n```jql\nsprint in closedSprints() AND resolution = Done\n```\n\nTeam capacity:\n```jql\nassignee in (user1, user2) AND sprint in openSprints()\n```\n\n### Dashboard Creation\n1. Create new dashboard (personal or shared)\n2. Add relevant gadgets:\n   - Filter Results (JQL-based)\n   - Sprint Burndown\n   - Velocity Chart\n   - Created vs Resolved\n   - Pie Chart (status distribution)\n3. Arrange layout for readability\n4. Configure automatic refresh\n5. Share with appropriate teams\n6. **HANDOFF TO**: Senior PM or Scrum Master for use\n\n### Automation Rules\n1. Define trigger (issue created, field changed, scheduled)\n2. Add conditions (if applicable)\n3. Define actions:\n   - Update field\n   - Send notification\n   - Create subtask\n   - Transition issue\n   - Post comment\n4. Test automation with sample data\n5. Enable and monitor\n\n## Advanced Features\n\n### Custom Fields\n**When to Create**:\n- Track data not in standard fields\n- Capture process-specific information\n- Enable advanced reporting\n\n**Field Types**: Text, Numeric, Date, Select (single\u002Fmulti\u002Fcascading), User picker\n\n**Configuration**:\n1. Create custom field\n2. Configure field context (which projects\u002Fissue types)\n3. Add to appropriate screens\n4. Update search templates if needed\n\n### Issue Linking\n**Link Types**:\n- Blocks \u002F Is blocked by\n- Relates to\n- Duplicates \u002F Is duplicated by\n- Clones \u002F Is cloned by\n- Epic-Story relationship\n\n**Best Practices**:\n- Use Epic linking for feature grouping\n- Use blocking links to show dependencies\n- Document link reasons in comments\n\n### Permissions & Security\n\n**Permission Schemes**:\n- Browse Projects\n- Create\u002FEdit\u002FDelete Issues\n- Administer Projects\n- Manage Sprints\n\n**Security Levels**:\n- Define confidential issue visibility\n- Control access to sensitive data\n- Audit security changes\n\n### Bulk Operations\n**Bulk Change**:\n1. Use JQL to find target issues\n2. Select bulk change operation\n3. Choose fields to update\n4. **Validate**: Preview all changes before executing; confirm the JQL filter matches only intended issues — bulk edits are difficult to reverse\n5. Execute and confirm\n6. Monitor background task\n\n**Bulk Transitions**:\n- Move multiple issues through workflow\n- Useful for sprint cleanup\n- Requires appropriate permissions\n- **Validate**: Run the JQL filter and review results in small batches before applying at scale\n\n## JQL Functions Reference\n\n> **Tip**: Save frequently used queries as named filters instead of re-running complex JQL ad hoc. See [Best Practices](#best-practices) for performance guidance.\n\n**Date**: `startOfDay()`, `endOfDay()`, `startOfWeek()`, `endOfWeek()`, `startOfMonth()`, `endOfMonth()`, `startOfYear()`, `endOfYear()`\n\n**Sprint**: `openSprints()`, `closedSprints()`, `futureSprints()`\n\n**User**: `currentUser()`, `membersOf(\"group\")`\n\n**Advanced**: `issueHistory()`, `linkedIssues()`, `issuesWithFixVersions()`\n\n## Reporting Templates\n\n> **Tip**: These JQL snippets can be saved as shared filters or wired directly into Dashboard gadgets (see [Dashboard Creation](#dashboard-creation)).\n\n| Report | JQL |\n|---|---|\n| Sprint Report | `project = PROJ AND sprint = 23` |\n| Team Velocity | `assignee in (team) AND sprint in closedSprints() AND resolution = Done` |\n| Bug Trend | `type = Bug AND created >= -30d` |\n| Blocker Analysis | `priority = Blocker AND status != Done` |\n\n## Decision Framework\n\n**When to Escalate to Atlassian Admin**:\n- Need new project permission scheme\n- Require custom workflow scheme across org\n- User provisioning or deprovisioning\n- License or billing questions\n- System-wide configuration changes\n\n**When to Collaborate with Scrum Master**:\n- Sprint board configuration\n- Backlog prioritization views\n- Team-specific filters\n- Sprint reporting needs\n\n**When to Collaborate with Senior PM**:\n- Portfolio-level reporting\n- Cross-project dashboards\n- Executive visibility needs\n- Multi-project dependencies\n\n## Handoff Protocols\n\n**FROM Senior PM**:\n- Project structure requirements\n- Workflow and field needs\n- Reporting requirements\n- Integration needs\n\n**TO Senior PM**:\n- Cross-project metrics\n- Issue trends and patterns\n- Workflow bottlenecks\n- Data quality insights\n\n**FROM Scrum Master**:\n- Sprint board configuration requests\n- Workflow optimization needs\n- Backlog filtering requirements\n- Velocity tracking setup\n\n**TO Scrum Master**:\n- Configured sprint boards\n- Velocity reports\n- Burndown charts\n- Team capacity views\n\n## Best Practices\n\n**Data Quality**:\n- Enforce required fields with field validation rules\n- Use consistent issue key naming conventions per project type\n- Schedule regular cleanup of stale\u002Forphaned issues\n\n**Performance**:\n- Avoid leading wildcards in JQL (`~` on large text fields is expensive)\n- Use saved filters instead of re-running complex JQL ad hoc\n- Limit dashboard gadgets to reduce page load time\n- Archive completed projects rather than deleting to preserve history\n\n**Governance**:\n- Document rationale for custom workflow states and transitions\n- Version-control permission\u002Fworkflow schemes before making changes\n- Require change management review for org-wide scheme updates\n- Run permission audits after user role changes\n\n## Atlassian MCP Integration\n\n**Primary Tool**: Jira MCP Server\n\n**Key Operations with Example Commands**:\n\nCreate a project:\n```\nmcp jira create_project --name \"My Project\" --key \"MYPROJ\" --type scrum --lead \"user@example.com\"\n```\n\nExecute a JQL query:\n```\nmcp jira search_issues --jql \"project = MYPROJ AND status != Done AND dueDate \u003C now()\" --maxResults 50\n```\n\nUpdate an issue field:\n```\nmcp jira update_issue --issue \"MYPROJ-42\" --field \"status\" --value \"In Progress\"\n```\n\nCreate a sprint:\n```\nmcp jira create_sprint --board 10 --name \"Sprint 5\" --startDate \"2024-06-01\" --endDate \"2024-06-14\"\n```\n\nCreate a board filter:\n```\nmcp jira create_filter --name \"Open Blockers\" --jql \"priority = Blocker AND status != Done\" --shareWith \"project-team\"\n```\n\n**Integration Points**:\n- Pull metrics for Senior PM reporting\n- Configure sprint boards for Scrum Master\n- Create documentation pages for Confluence Expert\n- Support template creation for Template Creator\n\n## Related Skills\n\n- **Confluence Expert** (`project-management\u002Fconfluence-expert\u002F`) — Documentation complements Jira workflows\n- **Atlassian Admin** (`project-management\u002Fatlassian-admin\u002F`) — Permission and user management for Jira projects\n","# Atlassian Jira Expert\n\nMaster-level expertise in Jira configuration, project management, JQL, workflows, automation, and reporting. Handles all technical and operational aspects of Jira.\n\n## Quick Start — Most Common Operations\n\n**Create a project**:\n```\nmcp jira create_project --name \"My Project\" --key \"MYPROJ\" --type scrum --lead \"user@example.com\"\n```\n\n**Run a JQL query**:\n```\nmcp jira search_issues --jql \"project = MYPROJ AND status != Done AND dueDate \u003C now()\" --maxResults 50\n```\n\nFor full command reference, see [Atlassian MCP Integration](#atlassian-mcp-integration). For JQL functions, see [JQL Functions Reference](#jql-functions-reference). For report templates, see [Reporting Templates](#reporting-templates).\n\n---\n\n## Workflows\n\n### Project Creation\n1. Determine project type (Scrum, Kanban, Bug Tracking, etc.)\n2. Create project with appropriate template\n3. Configure project settings:\n   - Name, key, description\n   - Project lead and default assignee\n   - Notification scheme\n   - Permission scheme\n4. Set up issue types and workflows\n5. Configure custom fields if needed\n6. Create initial board\u002Fbacklog view\n7. **HANDOFF TO**: Scrum Master for team onboarding\n\n### Workflow Design\n1. Map out process states (To Do → In Progress → Done)\n2. Define transitions and conditions\n3. Add validators, post-functions, and conditions\n4. Configure workflow scheme\n5. **Validate**: Deploy to a test project first; verify all transitions, conditions, and post-functions behave as expected before associating with production projects\n6. Associate workflow with project\n7. Test workflow with sample issues\n\n### JQL Query Building\n**Basic Structure**: `field operator value`\n\n**Common Operators**:\n- `=, !=` : equals, not equals\n- `~, !~` : contains, not contains\n- `>, \u003C, >=, \u003C=` : comparison\n- `in, not in` : list membership\n- `is empty, is not empty`\n- `was, was in, was not`\n- `changed`\n\n**Powerful JQL Examples**:\n\nFind overdue issues:\n```jql\ndueDate \u003C now() AND status != Done\n```\n\nSprint burndown issues:\n```jql\nsprint = 23 AND status changed TO \"Done\" DURING (startOfSprint(), endOfSprint())\n```\n\nFind stale issues:\n```jql\nupdated \u003C -30d AND status != Done\n```\n\nCross-project epic tracking:\n```jql\n\"Epic Link\" = PROJ-123 ORDER BY rank\n```\n\nVelocity calculation:\n```jql\nsprint in closedSprints() AND resolution = Done\n```\n\nTeam capacity:\n```jql\nassignee in (user1, user2) AND sprint in openSprints()\n```\n\n### Dashboard Creation\n1. Create new dashboard (personal or shared)\n2. Add relevant gadgets:\n   - Filter Results (JQL-based)\n   - Sprint Burndown\n   - Velocity Chart\n   - Created vs Resolved\n   - Pie Chart (status distribution)\n3. Arrange layout for readability\n4. Configure automatic refresh\n5. Share with appropriate teams\n6. **HANDOFF TO**: Senior PM or Scrum Master for use\n\n### Automation Rules\n1. Define trigger (issue created, field changed, scheduled)\n2. Add conditions (if applicable)\n3. Define actions:\n   - Update field\n   - Send notification\n   - Create subtask\n   - Transition issue\n   - Post comment\n4. Test automation with sample data\n5. Enable and monitor\n\n## Advanced Features\n\n### Custom Fields\n**When to Create**:\n- Track data not in standard fields\n- Capture process-specific information\n- Enable advanced reporting\n\n**Field Types**: Text, Numeric, Date, Select (single\u002Fmulti\u002Fcascading), User picker\n\n**Configuration**:\n1. Create custom field\n2. Configure field context (which projects\u002Fissue types)\n3. Add to appropriate screens\n4. Update search templates if needed\n\n### Issue Linking\n**Link Types**:\n- Blocks \u002F Is blocked by\n- Relates to\n- Duplicates \u002F Is duplicated by\n- Clones \u002F Is cloned by\n- Epic-Story relationship\n\n**Best Practices**:\n- Use Epic linking for feature grouping\n- Use blocking links to show dependencies\n- Document link reasons in comments\n\n### Permissions & Security\n\n**Permission Schemes**:\n- Browse Projects\n- Create\u002FEdit\u002FDelete Issues\n- Administer Projects\n- Manage Sprints\n\n**Security Levels**:\n- Define confidential issue visibility\n- Control access to sensitive data\n- Audit security changes\n\n### Bulk Operations\n**Bulk Change**:\n1. Use JQL to find target issues\n2. Select bulk change operation\n3. Choose fields to update\n4. **Validate**: Preview all changes before executing; confirm the JQL filter matches only intended issues — bulk edits are difficult to reverse\n5. Execute and confirm\n6. Monitor background task\n\n**Bulk Transitions**:\n- Move multiple issues through workflow\n- Useful for sprint cleanup\n- Requires appropriate permissions\n- **Validate**: Run the JQL filter and review results in small batches before applying at scale\n\n## JQL Functions Reference\n\n> **Tip**: Save frequently used queries as named filters instead of re-running complex JQL ad hoc. See [Best Practices](#best-practices) for performance guidance.\n\n**Date**: `startOfDay()`, `endOfDay()`, `startOfWeek()`, `endOfWeek()`, `startOfMonth()`, `endOfMonth()`, `startOfYear()`, `endOfYear()`\n\n**Sprint**: `openSprints()`, `closedSprints()`, `futureSprints()`\n\n**User**: `currentUser()`, `membersOf(\"group\")`\n\n**Advanced**: `issueHistory()`, `linkedIssues()`, `issuesWithFixVersions()`\n\n## Reporting Templates\n\n> **Tip**: These JQL snippets can be saved as shared filters or wired directly into Dashboard gadgets (see [Dashboard Creation](#dashboard-creation)).\n\n| Report | JQL |\n|---|---|\n| Sprint Report | `project = PROJ AND sprint = 23` |\n| Team Velocity | `assignee in (team) AND sprint in closedSprints() AND resolution = Done` |\n| Bug Trend | `type = Bug AND created >= -30d` |\n| Blocker Analysis | `priority = Blocker AND status != Done` |\n\n## Decision Framework\n\n**When to Escalate to Atlassian Admin**:\n- Need new project permission scheme\n- Require custom workflow scheme across org\n- User provisioning or deprovisioning\n- License or billing questions\n- System-wide configuration changes\n\n**When to Collaborate with Scrum Master**:\n- Sprint board configuration\n- Backlog prioritization views\n- Team-specific filters\n- Sprint reporting needs\n\n**When to Collaborate with Senior PM**:\n- Portfolio-level reporting\n- Cross-project dashboards\n- Executive visibility needs\n- Multi-project dependencies\n\n## Handoff Protocols\n\n**FROM Senior PM**:\n- Project structure requirements\n- Workflow and field needs\n- Reporting requirements\n- Integration needs\n\n**TO Senior PM**:\n- Cross-project metrics\n- Issue trends and patterns\n- Workflow bottlenecks\n- Data quality insights\n\n**FROM Scrum Master**:\n- Sprint board configuration requests\n- Workflow optimization needs\n- Backlog filtering requirements\n- Velocity tracking setup\n\n**TO Scrum Master**:\n- Configured sprint boards\n- Velocity reports\n- Burndown charts\n- Team capacity views\n\n## Best Practices\n\n**Data Quality**:\n- Enforce required fields with field validation rules\n- Use consistent issue key naming conventions per project type\n- Schedule regular cleanup of stale\u002Forphaned issues\n\n**Performance**:\n- Avoid leading wildcards in JQL (`~` on large text fields is expensive)\n- Use saved filters instead of re-running complex JQL ad hoc\n- Limit dashboard gadgets to reduce page load time\n- Archive completed projects rather than deleting to preserve history\n\n**Governance**:\n- Document rationale for custom workflow states and transitions\n- Version-control permission\u002Fworkflow schemes before making changes\n- Require change management review for org-wide scheme updates\n- Run permission audits after user role changes\n\n## Atlassian MCP Integration\n\n**Primary Tool**: Jira MCP Server\n\n**Key Operations with Example Commands**:\n\nCreate a project:\n```\nmcp jira create_project --name \"My Project\" --key \"MYPROJ\" --type scrum --lead \"user@example.com\"\n```\n\nExecute a JQL query:\n```\nmcp jira search_issues --jql \"project = MYPROJ AND status != Done AND dueDate \u003C now()\" --maxResults 50\n```\n\nUpdate an issue field:\n```\nmcp jira update_issue --issue \"MYPROJ-42\" --field \"status\" --value \"In Progress\"\n```\n\nCreate a sprint:\n```\nmcp jira create_sprint --board 10 --name \"Sprint 5\" --startDate \"2024-06-01\" --endDate \"2024-06-14\"\n```\n\nCreate a board filter:\n```\nmcp jira create_filter --name \"Open Blockers\" --jql \"priority = Blocker AND status != Done\" --shareWith \"project-team\"\n```\n\n**Integration Points**:\n- Pull metrics for Senior PM reporting\n- Configure sprint boards for Scrum Master\n- Create documentation pages for Confluence Expert\n- Support template creation for Template Creator\n\n## Related Skills\n\n- **Confluence Expert** (`project-management\u002Fconfluence-expert\u002F`) — Documentation complements Jira workflows\n- **Atlassian Admin** 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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\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Frisk-management-specialist\u002FSKILL.md",[],[108,109,110,111,112,113,40,114,115,116,117,34,118,119,120,121,122,123,124,125],"risk","risk management specialist","management","risk management","risk analysis","risk evaluation","Evaluation","Production","lifecycle","analysis","risk matrix","Market","control","iso","medical","iso 14971","identification","post",{"skillNo":127,"name":128,"nameZh":6,"description":129,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":130,"categories":131,"keywords":132,"publishedAt":46},"01M6EKFDZ7KES3X3HH8KBHR9JF","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\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fregulatory-affairs-head\u002FSKILL.md",[],[133,134,135,136,137,138,139,140,141,142,143,144,145,146,122,147,148,149,150,151],"regulatory affairs head","regulatory","head","documentation","documents","packages","plan","access","write","evidence","standards","intelligence","across","strategies","clinical","pathway","de","respond","medical devices",{"skillNo":153,"name":154,"nameZh":6,"description":155,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":156,"categories":157,"keywords":164,"publishedAt":46},"01M6EKF980P5MQBEQQAKB2JE6V","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\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qms-iso13485\u002FSKILL.md",[158,159],{"categoryNo":18,"categoryName":19,"taxonomyType":20,"taxonomyTypeDesc":21},{"categoryNo":160,"categoryName":161,"taxonomyType":162,"taxonomyTypeDesc":163},"01JBSEEDCAT000000000000032","设计师","PROFESSION","适用职业",[165,166,37,167,168,42,136,169,170,171,172,34,173,174,175,120,121,122,176,177],"quality manager qms iso13485","quality","review","support","audit","actions","compliance","system","up","maintenance","document","records","ISO 13485",{"skillNo":179,"name":180,"nameZh":6,"description":181,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":182,"categories":183,"keywords":187,"publishedAt":46},"01M6EKF4ZN8ZJJP3K6FM1WEM85","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\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-manager-qmr\u002FSKILL.md",[184],{"categoryNo":185,"categoryName":186,"taxonomyType":162,"taxonomyTypeDesc":163},"01JBSEEDCAT000000000000037","律师与法务",[188,166,167,189,190,191,192,171,193,172,110,194,134,195,196,197,121,177],"quality manager qmr","policy","performance","governance","monitoring","regulatory compliance","oversight","cost","culture","leadership",{"skillNo":199,"name":200,"nameZh":6,"description":201,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":202,"categories":203,"keywords":208,"publishedAt":46},"01M6EKF15YKH2AQB45MH4Y6S08","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\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fquality-documentation-manager\u002FSKILL.md",[204,207],{"categoryNo":205,"categoryName":206,"taxonomyType":20,"taxonomyTypeDesc":21},"01JBSEEDCAT000000000000002","文档处理",{"categoryNo":185,"categoryName":186,"taxonomyType":162,"taxonomyTypeDesc":163},[136,209,166,167,45,210,169,116,211,172,212,213,214,215,216,122,217,218,219,220],"quality documentation manager","change","document lifecycle","change management","list","master","system management","documentation review","cfr","21 cfr part 11","change control","retention",{"skillNo":222,"name":223,"nameZh":6,"description":224,"descriptionZh":6,"repositoryFullName":8,"ownerLogin":9,"ownerAvatarUrl":10,"ownerAccountNo":11,"ownerDisplayName":6,"repositoryNo":12,"starsCount":13,"licenseSpdxId":14,"licenseFileUrl":6,"sourceHtmlUrl":225,"categories":226,"keywords":227,"publishedAt":46},"01M6EKEXQMCQC11A5WR9GEPC4S","qms-audit-expert","ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.","https:\u002F\u002Fgithub.com\u002FArogyaReddy\u002Falirezarezvani-claude-skills\u002Fblob\u002Fmain\u002Fra-qm-team\u002Fqms-audit-expert\u002FSKILL.md",[],[169,228,26,41,229,230,231,232,110,34,233,234,121,122,177],"qms audit expert","verification","execution","classification","schedule","checklist","device"]