Head of Quality Management

About this role

About Vitec Neagen Oy

Vitec Neagen Oy is a Finnish software company developing competitive, standardized high-technology products for medical imaging. Founded in 2002 by a medical image processing research group at the University of Oulu and Oulu University Hospital, we combine academic insight, clinical experience, and strong technical expertise into proven products and solutions. Headquartered in Oulu with additional operations in Helsinki, we became part of the Vitec Software Group in 2023. We work closely with clinicians and specialists to continuously improve our software. At Vitec Neagen, you will find a supportive team, meaningful work, and opportunities for growth. Learn more about us at: www.neagen.com Head of Quality Management (ISO 13485 / IEC 62304) We are looking for a Head of Quality Management to lead further develop our quality management processes in a software development-focused environment. Our work involves regulated products, and this role helps ensure our solutions meet relevant standards while staying practical for development teams. You will work closely with a small, experienced team in a low-hierarchy setting. What you will be working on: Manage and continuously improve our Quality Management System (ISO 13485) Lead software-related processes in line with IEC 62304 Ensure compliance with regulatory requirements Work together with developers to keep quality practices simple and usable Help prepare for and participate in audits (internal and external) Keep documentation clear, up to date, and easy to understand Suggest improvements when something could work better in practice Explore innovative ways to improve processes, including the use of AI/LLM tools Train and guide employees on process improvements and their practic