quality-manager-qms-iso13485

SKILL.md

Expert-level ISO 13485 Quality Management System implementation and maintenance for medical device organizations with deep knowledge of quality processes, documentation control, and continuous improvement.

ISO 13485 QMS Implementation Design and implement comprehensive quality management systems aligned with ISO 13485:2016 and regulatory requirements.

Document Control System (ISO 13485 Clause 4.2.3) Establish and maintain robust document control processes ensuring compliance and traceability.

ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities. Source: ovachiever/droid-tings.

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