Agent Skills Directory

Google Workspace administration via the gws CLI. Install, authenticate, and automate Gmail, Drive, Sheets, Calendar, Docs, Chat, and Tasks. Run security audits, execute 43 built-in recipes, and use 10 persona bundles. Use for Google Workspace admin, gws CLI setup, Gmail automation, Drive management, or Calendar scheduling.

Operations leadership for scaling companies. Process design, OKR execution, operational cadence, and scaling playbooks. Use when designing operations, setting up OKRs, building processes, scaling teams, analyzing bottlenecks, planning operational cadence, or when user mentions COO, operations, process improvement, OKRs, scaling, operational efficiency, or execution.

CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.

The meta-framework for how a company runs — the connective tissue between all C-suite roles. Covers operating system selection (EOS, Scaling Up, OKR-native, hybrid), accountability charts, scorecards, meeting pulse, issue resolution, and 90-day rocks. Use when setting up company operations, selecting a management framework, designing meeting rhythms, building accountability systems, implementing OKRs, or when user mentions EOS, Scaling Up, operating system, L10 meetings, rocks, scorecard, accountability chart, or quarterly planning.

Microsoft 365 tenant administration for Global Administrators. Automate M365 tenant setup, Office 365 admin tasks, Azure AD user management, Exchange Online configuration, Teams administration, and security policies. Generate PowerShell scripts for bulk operations, Conditional Access policies, license management, and compliance reporting. Use for M365 tenant manager, Office 365 admin, Azure AD users, Global Administrator, tenant configuration, or Microsoft 365 automation.

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.

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.

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 2017/745; 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.

Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. 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.