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Found 4 Skills
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.
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.
Expert-level ISO standards, quality management, compliance, and certification