Vitec Neagen Oy: Head of Quality Management (ISO 13485 / IEC 62304)
Location: Rotuaari, Oulu, Finland
Employment: Full-time, permanent
Salary range: €5,000–€7,500 (based on skills and experience)
Application deadline: 31.5.2026
About us
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:
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Manage and continuously improve our Quality Management System (ISO 13485)
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Lead software-related processes in line with IEC 62304
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Ensure compliance with regulatory requirements
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Work together with developers to keep quality practices simple and usable
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Help prepare for and participate in audits (internal and external)
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Keep documentation clear, up to date, and easy to understand
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Suggest improvements when something could work better in practice
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Explore innovative ways to improve processes (e.g. AI/LLM tools)
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Train and guide employees on process improvements and their practical application
Requirements
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Experience with ISO 13485 and IEC 62304 standards
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Basic understanding of software development practices (e.g. testing, version control, release processes)
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Experience working with quality systems, documentation, or audits
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Lean thinking and pragmatic approach to work
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Ability to work both independently and together with a team
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Fluency in English and Finnish (written and spoken)
Considered an asset
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Previous experience with medical device software
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Familiarity with risk management (e.g., ISO 14971)
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Familiarity with Medical Device Directive (93/42/EEC) and Medical Device Regulation (EU 2017/745)
If most of this sounds familiar, we encourage you to apply!
What we offer
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Opportunity to work on meaningful solutions used by top-level healthcare professionals
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A professional yet relaxed and supportive work atmosphere in a small team
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Flexible working hours and hybrid work possibilities, with a centrally located office in Rotuaari
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Competitive salary aligned with your experience and skills (range €5,000–7,500/month) with room to grow
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Stability and support as part of the Vitec Software Group
How to apply?
Please send your CV and cover letter to: [email protected] no later than 31.5.2026.
In your application, you please include:
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Relevant experience or examples related to quality management systems or regulated environments
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Your salary expectations (or salary range) and earliest possible start date
We look forward to hearing from you!