Quality Assurance Labelling Manager - EMEA - Medical Devices

As a successful Quality Assurance Labelling Manager - Medical Device company you will have the following responsibilities:

Leadership activities:

• Lead the Quality Assurance Labelling teams, ensuring continuous improvement and regulatory compliance.
• Contribute to the strategic planning and direction of the Quality Assurance department.
• Oversee the training of staff in labelling procedures and regulatory requirements.
• Develop and implement labelling procedures, quality processes and quality control measures in compliance with ISO 13485.
• Work collaboratively with other departments to streamline labelling processes (Regulatory Affairs, supply chains, Business Units...).

Quality Assurance:

• Be responsible for labeling activities requests from the initiation until the approval.
• Ensure all labelling activities adhere to international regulatory standards and compliance ( ISO 13485, GDP, GMP, MDR, and IVDR regulations).
• Handle EMEA products complaints, CAPAs and deviations linked to labelling activities.
• Conduct & Coordinate regular audits and reviews to ensure labelling accuracy.
• Manage labelling documentation, maintaining records of all quality assurance activities.