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We currently have the following opportunity available - please contact us for more details!
Are you passionate about driving quality excellence and ensuring that life‑changing 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 cross‑functional 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 decision‑making skills.
Experience working independently in a global, regulated environment.
Excellent written and verbal communication skills in English.
Proactive, pragmatic, and continuous‑improvement 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 mission‑driven organization and help shape world‑class 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.