Quality Systems Manager

About the role

The Quality Systems Manager oversees the implementation, maintenance and continuous improvement of the site’s Quality Management System (QMS). This role ensures compliance with regulatory requirements and supports business objectives through effective quality processes.

Key responsibilities

• Manage core QMS processes including document control, change control, CAPA, non‑conformances, planned deviations, training and internal audits.
• Ensure QMS compliance with ISO 13485, 21 CFR Part 820 and other applicable regulations.
• Lead regulatory inspections and audits, prepare responses and drive remediation of findings.
• Maintain and update local QMS procedures aligned with corporate policies.
• Coordinate and conduct internal audits, act as lead auditor and report findings.
• Support Management Review with data‑driven insights and monitor QMS KPIs.
• Drive risk‑based CAPA activities and perform trending and data analysis of quality metrics.
• Mentor and develop quality system personnel, promote a quality culture and ensure training effectiveness.

Required profile

• Bachelor’s degree in a related field.
• Minimum 5 years of experience in quality systems, preferably within medical device or regulated environments.
• Strong understanding of regulatory standards such as ISO 13485 and 21 CFR Part 820.
• Proven ability to lead audits, manage CAPA processes and drive continuous improvement.

Required skills

• ISO 13485
• 21 CFR Part 820
• CAPA management
• Internal audit execution
• Risk management
• Data analysis and KPI reporting