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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.