CQ/RA Specialist BeNeLux
Core
Support and maintain the Quality Management System (QMS) for MedTech businesses in Belgium and Luxembourg, ensuring compliance with quality requirements and regulatory expectations.
Role type
Quality Management System Specialist (MedTech)
Builds
Quality processes, documentation, and compliance activities for commercial teams
Domain
Medical Technology / Healthcare
Required skills
Quality Management Systems, Regulatory Affairs, CAPA management, Non-conformance handling, Complaint investigations, Field Safety Notices, Recall management, Document control, Internal auditing, Supplier auditing, Change control, Data integrity, GxP principles, Training delivery, Microsoft Office
Preferred skills
ISO 13485 knowledge, Healthcare industry experience, Multinational organization experience, Internal ISO auditor certification
Technologies
Microsoft Office (Excel, Word, PowerPoint), QMS digital tools
Responsibilities
Manage and support quality processes including CAPAs, non-conformances, complaint investigations, Field Safety Notices, recalls, document control, and training systems; Plan and lead internal audits and support supplier audits; Coach and train employees on quality-related topics; Lead change control activities and support quality system improvements; Create and maintain standard operating procedures related to interactions with contractors; Monitor and maintain quality records, project outcomes, and quality metrics.
Seniority
Mid-level, hands-on IC