Quality Specialist – 12‑Month Freelance Contract

About the role

We are looking for an experienced Quality Specialist to join a leading medical device organisation in Brussels on a 12‑month freelance contract. The role focuses on quality remediation activities and ensuring compliance with ISO 13485 within a regulated environment, working in a hybrid setting (three days onsite, two days remote).

Key responsibilities

• Support quality remediation projects across all QMS processes.
• Conduct gap analyses against ISO 13485 requirements.
• Identify non‑conformities and drive corrective and preventive actions (CAPAs).
• Collaborate with QA/RA, manufacturing and engineering teams.
• Update documentation, SOPs and assist with audit readiness.
• Contribute to continuous improvement initiatives within the quality management system.

Required profile

• Proven experience as a Quality Specialist or Quality Engineer in the medical device industry.
• Strong working knowledge of ISO 13485 and QMS.
• Hands‑on experience with remediation projects, gap analysis and audit support.
• Excellent communication and stakeholder management skills.
• Ability to work independently in a fast‑paced environment.

Required skills

• ISO 13485
• Quality Management System (QMS)
• Gap analysis
• Corrective and Preventive Actions (CAPA)
• Audit support
• Documentation and SOP management