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Quality Assurance Engineer
full-time•Veenendaal
About this role
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We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.
We currently have the following opportunity available - please contact us for more details!
The core task of the Quality Assurance Engineer is to ensure compliance to the current standards and regulations that apply to the Medical Device Industry. As member of a team of QA engineers, you will collaborate with functional teams in different disciplines to develop medical devices, drive processes and host audits.
As a Quality Assurance Engineer, you will play a critical role in ensuring that the products and processes of our Business Line Brachy products are safe and effective and meet the required regulatory standards. You will be part of the QA team (3p) and together with the Regulatory team (3p), both teams form the RAQ department. These teams collaborate with other functional teams in areas such as Engineering, Order Fulfillment, Sales & Marketing, and Manufacturing Engineering.
The Responsibilities
Ensure product compliance of an assigned value stream (e.g. applicators and materials used within brachy medical devices)
Support the local and global Quality Management System (QMS) and processes
Represent QA organization in specific processes (NC, CAPA, complaints) or other functions with technical expertise (e.g. Order fulfilment, Manufacturing, etc.)
Ensure accurate reporting and documentation for quality assurance processes
Analyze process data and trends to drive optimization
Participate in external audits for regulatory authorities and Notified Bodies
Participate in the execution of the internal audit plan.
Main focus will be to ensure our Xoft products and processes, as managed through the San Jose site, are in compliance.
What you'll do
- The Quality Assurance Engineer ensures compliance with standards and regulations in the Medical Device Industry. They collaborate with various functional teams to develop medical devices and participate in audits.
About Elekta
Each year, millions of people hear the words no one wants to hear: "You have cancer." And behind each diagnosis lies a unique story, a family that deserves hope, a future that's worth fighting for. We know that no two treatment journeys are the same and delivering care is far from simple. It's complex, urgent, and deeply human. That’s why we don’t back down from challenges—we rise to them. From the smallest tumor change to the toughest clinical decisions, we see every obstacle as an opportunity to progress. That is what drives us. The people undergoing treatment. The clinicians providing the care. We are united in purpose. Together, we can create a world where every patient has access to the highest standard of care. This is our commitment because for everyone, it's personal. We are leading the innovation in personalized radiation therapy solutions. We are Elekta.
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Frequently Asked Questions
What does a Quality Assurance Engineer do at Elekta?
As a Quality Assurance Engineer at Elekta, you will: the Quality Assurance Engineer ensures compliance with standards and regulations in the Medical Device Industry. They collaborate with various functional teams to develop medical devices and participate in audits..
Is the Quality Assurance Engineer position at Elekta remote?
The Quality Assurance Engineer position at Elekta is based in Veenendaal, Utrecht, Netherlands. Contact the company through Clera for specific work arrangement details.
How do I apply for the Quality Assurance Engineer position at Elekta?
You can apply for the Quality Assurance Engineer position at Elektadirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.