Senior Quality Assurance Specialist

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Please click here to apply through our internal career site Find Jobs - Elekta.

Want to join a team with a mission to improve and save lives?

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!

Join Us in Shaping the Future of Precision Cancer Care

AtElekta, we are committed to developing innovative solutions that help clinicians improve outcomes for patients worldwide. To support our mission, we are now looking for aSenior Quality Assurance Specialistto strengthen our Quality Management System (QMS) team.

In this role, you will be a key contributor to the structure, governance, and continuous improvement of the Elekta Solutions Management System, ensuring compliance with global medical device regulations and the highest standards of quality. If you thrive in a collaborative, regulated environment and enjoy driving quality excellence, this role is for you.

What You Will Do

As a Senior Quality Assurance Specialist, you will:

• Support the implementation, maintenance, and ongoing improvement of QMS processes across the organization.
• Promote quality culture by driving understanding and adherence to QMS structure and principles.
• Identify, propose, and implement system improvements to enhance efficiency and performance.
• Lead QMS process performance management, including KPIs, dashboards, and governance routines.
• Plan, host, and conduct internal audits to ensure regulatory compliance.
• Support preparations for external audits and participate actively during audits.
• Manage QMS nonconformities and coordinate Corrective and Preventive Actions (CAPAs).
• Provide QMS training, guidance, and best practice support across the organization.
• Serve as process lead and subject matter expert for document management processes.
• Provide operational leadership to regional QA, including workload coordination and escalation handling.
• Contribute to long-term QMS roadmap, structural improvements, and harmonization initiatives.

What You Bring

To succeed in this role, you should have:

• Extensive experience in Quality Assurance or Regulatory Affairs within medical devices or pharmaceuticals.
• Strong working knowledge of ISO 13485, EU MDR, MDSAP, and US FDA QSMR, with internal audit experience or formal auditor training.
• Hands-on experience with document control, nonconformities, and CAPA management.
• Proven ability to oversee QMS improvements, performance metrics, and compliance governance.
• Excellent communication skills in English, enabling collaboration in a global environment.
• Ability to provide QMS process training to diverse teams.
• A structured and analytical approach with strong problem-solving skills and attention to detail.
• A proactive, adaptable mindset with the ability to work independently and drive initiatives.
• A scientific university degree or equivalent background.

Why Join Elekta?

At Elekta, your work will contribute to shaping the future of cancer treatment and improving the lives of patients worldwide. You will work in a supportive, mission-driven environment where innovation, collaboration, and continuous improvement are part of our DNA.

Ready to Make an Impact?

If you are passionate about quality, motivated by meaningful work, and ready to influence global processes in a leading medtech company, we would love to hear from you.

Apply today and help us create a world where everyone has access to precision cancer care.