quality-documentation-manager

SKILL.md

Expert-level quality documentation management with comprehensive document control system design, regulatory documentation oversight, change management, and configuration control for medical device organizations.

Document Control System Design (ISO 13485 Clause 4.2.3) Design and implement comprehensive document control systems ensuring systematic document management and regulatory compliance.

Regulatory Documentation Oversight Provide comprehensive oversight of regulatory documentation ensuring compliance with multiple jurisdictional requirements.

Senior Quality Documentation Manager for comprehensive documentation control and regulatory document review. Provides document management system design, change control, configuration management, and regulatory documentation oversight. Use for document control system implementation, regulatory document review, change management, and documentation compliance verification. Source: ovachiever/droid-tings.

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