Senior QMS Audit Expert for internal and external quality management system auditing. Provides ISO 13485 audit expertise, audit program management, nonconformity identification, and corrective action verification. Use for internal audit planning, external audit preparation, audit execution, and audit follow-up activities.
8.1
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0
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Business & Productivity
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Excellent comprehensive QMS audit skill with strong ISO 13485 expertise. The description clearly covers audit planning, execution, nonconformity management, and CAPA integration, making it easy for a CLI agent to determine when to invoke this skill. Task knowledge is extensive with detailed frameworks, processes, and decision points, plus references to supporting scripts and documents. Structure is well-organized with logical sections and clear hierarchies, though the single-file format is dense. Novelty is good - QMS auditing requires specialized domain expertise (ISO 13485, risk-based planning, auditor competency frameworks) that would be challenging for a general CLI agent to replicate without significant token expenditure. The skill meaningfully packages complex regulatory and audit methodology knowledge into a reusable format. Minor improvement areas: could benefit from more concrete examples of audit findings or case studies, and the skill could be slightly more modular by splitting some detailed frameworks into separate reference files.
davila7
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