Senior Quality Management Engineer

Stockholm, Sweden
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

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)

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

• 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

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\.

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