Quality Officer

Quality Assurance Officer

Location: Flemish Region, Belgium

Working Pattern: 40 hours per week | Hybrid (2 days on-site, 3 days remote)

Overview

A leading medical device organisation is seeking a Quality Assurance Officer to support and maintain its Quality Management System while ensuring compliance with applicable regulatory and quality requirements.

This position offers the opportunity to work within a highly regulated environment, supporting quality operations across document control, CAPA management, audits, non-conformities and continuous improvement initiatives.

Key Responsibilities

• Manage quality documentation, ensuring accurate control, review and maintenance of quality records and procedures.
• Support the ongoing maintenance and improvement of the Quality Management System (QMS).
• Coordinate and follow up on Corrective and Preventive Actions (CAPAs), ensuring timely closure and effectiveness.
• Support internal and external audits, including preparation of documentation and follow-up of audit findings.
• Investigate non-conformities and quality issues, ensuring appropriate root cause analysis and corrective actions.
• Monitor compliance with internal quality procedures and applicable medical device quality standards.
• Collaborate with cross-functional teams to drive continuous improvement initiatives and strengthen quality processes.
• Assist in the preparation, review and implementation of quality documentation and procedures.

Requirements

• Experience within Quality Assurance in medical device industry
• Knowledge of Quality Management Systems and quality processes.
• Experience with CAPA management, document control and non-conformance handling.
• Familiarity with internal and external audit activities.
• Understanding of applicable quality and regulatory requirements, including ISO 13485 knowledge being advantageous.
• Strong organisational skills with excellent attention to detail.
• Ability to work independently while collaborating effectively with cross-functional teams.

What's on Offer

• Hybrid working model with flexibility.
• Opportunity to work within an innovative and regulated medical device environment.
• Exposure to a broad range of quality activities and continuous improvement projects.
• Collaborative and supportive team culture.