We don’t just build technology. We build hope for everyone dealing with cancer.
About the Team
You will join the Quality Management team, working closely with Engineering, Regulatory and cross-functional project teams across the organization.
You will act as a key partner to ensure that our products meet the highest standards of quality, safety and regulatory compliance throughout the lifecycle. This role is based in Stockholm and requires close day-to-day collaboration with local development teams.
What You Will Do
In this role, you will:
Act as Quality representative in design and development projects, providing guidance on quality systems and regulatory requirements
Support cross-functional teams in applying quality and regulatory processes throughout the development lifecycle
Contribute to and approve quality documentation across the product lifecycle
Manage non-conformances, CAPA and related quality improvements
Maintain and improve the Quality Management System
Plan, prepare and participate in internal and external audits such as FDA or notified bodies
Support regulatory compliance activities, including responses to governing agencies
Train and coach teams on quality processes and standards
Drive continuous improvement across quality systems and ways of working
What You Bring
We believe you bring:
A university degree in Engineering or a related field
Experience working with quality management systems and/or regulatory affairs, ideally within a medical device environment
Knowledge of relevant standards and regulations such as EU MDR, FDA QSR, ISO 13485, MDSAP, ISO 14971 and IEC 62304
Experience within the medical device, pharmaceutical, or broader life sciences industry, including exposure to audits and/or software-related product development
Experience in design and development and risk management processes
Strong analytical and problem-solving skills with a structured approach
Excellent communication skills and ability to collaborate across functions and cultures
Fluency in English (written and spoken)
Who You Are
You are someone who:
Demonstrates high integrity and sound judgment in regulated environments
Translates regulatory requirements into practical business application
Thrives in a collaborative, cross-functional environment
Communicates effectively with stakeholders at all levels
Takes ownership and drives work forward proactively
Applies a structured and methodical approach to problem solving
Why Join Elekta?
30 paid vacation days per year
4 additional Elekta days off (plus bank holidays)
Defined contribution pension scheme
Private Medical Insurance
Lunch Benefit
Contribution to wellness activities
Application Process
We are looking forward to hearing from you! Apply by submitting your application Please note that we do not accept applications by e-mail. Last day for applying is July 8th, 2026.
