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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!

Are you passionate about driving quality excellence and ensuring that lifechanging medical technologies meet the highest standards At Elekta we are committed to improving patient outcomes worldwide and we are now looking for a Region QA & QMS Governance Manager to strengthen our Quality Management System (QMS) and support our global mission.

About the role

We are looking for an experienced Region QA & QMS Governance Manager to lead and continuously strengthen the Quality Management System (QMS) across assigned regions while also contributing to global QMS governance. This is a senior role with significant influence on how quality compliance and continuous improvement are embedded across the organization.

You will act as a central expert and leader for QMS structure governance and performance ensuring robust compliance with regulatory and certification requirements while driving harmonization and efficiency across regions and entities.

Key responsibilities

• Lead and ensure effective implementation performance and compliance of the regional QMS aligned with global governance.

• Develop maintain and harmonize global QMS processes and roadmap.

• Ensure audit and certification readiness; coordinate internal audits and manage external audits with regulators and Notified Bodies.

• Drive effective management of audit findings nonconformances and CAPAs including root cause analysis and systemic improvements.

• Monitor QMS performance through KPIs dashboards audits and governance forums.

• Own document control governance and act as SME for EDMS/eQMS (e.g. MasterControl) including configuration validation and access control.

• Promote a strong quality culture and consistent QMS principles across regions and functions.

• Lead coach and prioritize work for regional QA and QMS governance teams.

• Deliver QMS and regulatory training to crossfunctional stakeholders.

• Serve as senior advisor on ISO 13485 EU MDR MDSAP FDA QSMR and related standards.

Authorities

• Approve QMS documentation records and system changes.

• Approve audits nonconformances concessions and related QA decisions.

• Act as regional Quality Management Representative.

• Govern EDMS/eQMS configuration and releases.

• Establish and approve QMS and document control metrics and dashboards.

• Escalate systemic quality issues and contribute to budget planning where applicable.

Your profile

• Extensive QA and/or Regulatory Affairs experience within medical devices or pharmaceuticals.

• Strong working knowledge of ISO 13485 EU MDR MDSAP and FDA QSMR.

• Qualified internal auditor (formal training or equivalent experience).

• Proven expertise in document control nonconformance management and CAPA processes.

• Demonstrated leadership capability with strong prioritization and decisionmaking skills.

• Experience working independently in a global regulated environment.

• Excellent written and verbal communication skills in English.

• Proactive pragmatic and continuousimprovement mindset.

• High integrity with a strong commitment to quality and compliance.

• Scientific university degree or equivalent relevant background.

Why join us

This role offers an opportunity to make a real impact on how quality systems are governed and continuously improved in a regulated global environment. You will work closely with senior stakeholders lead experienced teams and shape the future of QMS governance.

Ready to make a difference

If you want to contribute to a missiondriven organization and help shape worldclass quality standards across regions we would love to hear from you.

Apply today and join us in shaping the future of radiation therapy and oncology solutions.