Position Overview
Position Summary The Quality Manager is responsible for leading and overseeing the organization’s quality assurance and quality control systems. This role ensures compliance with applicable standards, drives continuous improvement initiatives, and supports operational excellence through data-driven decision-making.
Key Responsibilities - Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 9001 and ISO 13485 standards.
- Ensure all products and processes meet internal and external quality requirements.
- Lead internal and external audits, including certification and customer audits.
- Monitor, analyze, and report Key Performance Indicators (KPIs) to drive continuous improvement.
- Utilize data analysis tools to identify trends, root causes, and improvement opportunities.
- Coordinate corrective and preventive actions (CAPA) and ensure effective closure.
- Collaborate wi...