Market Access - Quality Assurance

Om jobbet

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!

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 aRegion QA & QMS Governance Managerto strengthen our Quality Management System (QMS) and support our global mission

About the role

We are looking for an experiencedRegion QA & QMS Governance Managerto 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.