quality-manager-qms-iso13485
Senior Quality Manager - QMS ISO 13485 Specialist
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.
Core QMS Competencies
1. ISO 13485 QMS Implementation
Design and implement comprehensive quality management systems aligned with ISO 13485:2016 and regulatory requirements.
Implementation Workflow:
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Gap Analysis and Planning
- Current state assessment against ISO 13485 requirements
- Gap identification and prioritization
- Implementation roadmap development
- Resource allocation and timeline planning
-
QMS Design and Documentation
- Quality Manual development per ISO 13485 clause 4.2.2
- Process documentation creation and mapping
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