Senior Quality Management Engineer

About the role

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.

Responsibilities

• 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)

Requirements

• 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 via the "Apply" button. Please note that we do not accept applications by e-mail. Last day for applying is July 8th, 2026.

Benefits

Additional Information

Are you a current Elekta employee? 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! We don't just build technology. We build hope for everyone dealing with cancer.

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