Elekta

QMS Governance Manager

Warsaw Full time

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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!

Join Elekta and Make a Meaningful Impact

At Elekta, we pioneer precision radiation medicine that directly improves and saves lives. As we continue strengthening our global Quality Management System, we are looking for a passionate and experienced QMS Governance Manager to help shape the governance, structure, and continuous improvement of the Elekta Solutions Management System.

This is a key role for someone who thrives in a highly regulated environment, enjoys leading quality initiatives, and wants to drive harmonization and excellence across a global organization.

What You Will Do

As the QMS Governance Manager, you will serve as a central expert and leader within Elekta’s QMS function. Your responsibilities include:

Quality System Leadership

  • Lead the implementation, maintenance, and improvement of processes across the Elekta Solutions QMS.

  • Promote a strong quality culture across the organization.

  • Drive system effectiveness through performance monitoring, KPIs, dashboards, and governance routines.

Audit & Compliance

  • Plan, host, and conduct internal audits.

  • Support and participate in external audits.

  • Manage quality system nonconformities, including CAPAs, from initiation to closure.

Document Control & EDMS Ownership

  • Serve as process lead and subject-matter expert for document control.

  • Govern Elekta’s Electronic Document Management System (MasterControl), including configuration, validation, access management, vendor coordination, and release planning.

Team Leadership

  • Provide operational leadership to the QMS Team, including daily coordination, workload management, coaching, and reporting.

  • Drive long-term QMS harmonization and roadmap activities.


 What You Bring

We are looking for someone who combines QMS excellence with strong leadership and communication skills.

Qualifications & Competencies

  • Extensive experience in Quality Assurance or Regulatory Affairs within medical devices or pharmaceuticals.

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

  • Experience in internal auditing (training or certification preferred).

  • Hands-on expertise in managing document controls, nonconformities, and CAPAs.

  • Ability to deliver QMS training and support continuous improvement initiatives.

  • Excellent communication skills in English; able to collaborate across global teams.

  • Proactive, adaptable mindset with strong integrity and a commitment to quality.

  • Higher education degree in a scientific or relevant technical field.

  • Leadership experience with demonstrated ability to prioritize, guide, and support a team.

Why Join Elekta?

  • Work in a mission-driven organization improving patient outcomes worldwide.

  • Be part of a global Quality & Regulatory Affairs function with a high level of influence.

  • Drive strategic improvements and shape Elekta’s QMS of the future.

  • Collaborate with experts across diverse technical and clinical domains.

Ready to Make a Difference?

If you’re passionate about quality leadership in a highly regulated, purpose-driven environment, we’d love to hear from you.