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Found 11 Skills
Implements and enforces code quality gates for TypeScript/React projects. Use when setting up Biome/ESLint/TypeScript, configuring pre-commit hooks (Husky), fixing lint errors, or running quality checks. Examples - "setup code quality", "fix lint errors", "configure Biome", "run quality checks".
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.
Senior CAPA Officer specialist for managing Corrective and Preventive Actions within Quality Management Systems. Provides CAPA process management, root cause analysis, effectiveness verification, and continuous improvement coordination. Use for CAPA investigations, corrective action planning, preventive action implementation, and CAPA system optimization.
12 production-ready regulatory affairs and quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO compliance, risk management (ISO 14971), CAPA, document control, and internal auditing. Python tools included (all stdlib-only). Works with Claude Code, Codex CLI, and OpenClaw.
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.
When the user wants to create SEO-driven pages at scale using templates and data. Also use when the user mentions "programmatic SEO," "template pages," "pages at scale," "directory pages," "location pages," "[keyword] + [city] pages," "comparison pages," "integration pages," or "building many pages for SEO." For auditing existing SEO issues, see review-seo-audit.
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
Conduct Failure Mode and Effects Analysis (FMEA) for systematic identification and risk assessment of potential failures in designs, processes, or systems. Supports DFMEA (Design), PFMEA (Process), and FMEA-MSR (Monitoring & System Response). Uses AIAG-VDA 7-step methodology with Action Priority (AP) risk assessment replacing traditional RPN. Use when analyzing product designs for potential failures, evaluating manufacturing process risks, conducting proactive risk assessment, preparing for APQP/PPAP submissions, investigating field failures, or when user mentions "FMEA", "failure mode", "DFMEA", "PFMEA", "severity occurrence detection", "RPN", "Action Priority", "design risk analysis", or needs to identify and prioritize potential failure modes with their causes and effects.
Codified expertise for quality control, non-conformance investigation, root cause analysis, corrective action, and supplier quality management in regulated manufacturing. Informed by quality engineers with 15+ years experience across FDA, IATF 16949, and AS9100 environments. Includes NCR lifecycle management, CAPA systems, SPC interpretation, and audit methodology. Use when investigating non-conformances, performing root cause analysis, managing CAPAs, interpreting SPC data, or handling supplier quality issues.
Expert-level ISO standards, quality management, compliance, and certification
Review and delivery persona for PR quality management and progress tracking in the SWE workflow.