Quality Systems Coordinator II

About the role

The Quality Systems Coordinator II supports the sustaining of the plant's Quality Management System. This role ensures documentation, compliance, and continuous improvement of quality processes.

Key responsibilities

• Guarantee full compliance of all ACA, CAPA and customer complaint investigations.
• Follow up open quality figures such as ACA, CAPA, customer complaints and PA.
• Coach investigators throughout the investigation process.
• Coordinate and measure activities related to maintaining the Quality Management System.
• Maintain plant-wide quality metrics and support external audit preparation.
• Participate in internal audit teams and provide support to the release area.
• Ensure compliance with ISO 13485, CFR Part 820, Good Manufacturing Practices and safety/housekeeping (6S) standards.

Required profile

• High school diploma.
• Currently enrolled as a term student in Industrial Engineering or a related field.
• Minimum three years of equivalent job experience.
• Proficiency in English.

Required skills

• Knowledge of ISO 13485 quality management standards.
• Understanding of CFR Part 820 medical device regulations.
• Experience with CAPA (Corrective and Preventive Action) management.