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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 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 Quality Assurance Manager to strengthen our Quality Management System (QMS) and support our global mission.

LOCATION: Atlanta, 4 days in the office

About the role

As Region Quality Assurance Manager, you will play a central role in maintaining and improving the Elekta Solutions Management System. You will act as a trusted expert and advisor for Quality Assurance across the regional organization - supporting compliance, consistency, and continuous improvement.

This role combines hands-on quality system oversight, operational leadership, and strategic QMS development. You will collaborate closely with cross-functional teams and ensure we meet regulatory expectations in a fast-moving international environment.

You will report to the Director Quality Management System.

We don't just build technology. We build hope for everyone dealing with cancer.

LOCATION: Atlanta, GA - 4 days in the office

What You Will Do

Quality System Leadership

• Lead the effective implementation and ongoing compliance of the regional Quality Management System (QMS).
• Maintain end-to-end accountability for regional QMS outcomes, including audit results, certifications, and regulatory readiness.
• Coordinate and maintain required local permits, licenses, and regulatory approvals, including QMS certifications.

Governance & Compliance

• Monitor QMS performance through KPIs, dashboards, audits, and governance routines.
• Plan and conduct internal audits, support external audits, and ensure timely closure of audit findings.
• Manage non-conformities and CAPAs, ensuring effective root cause investigation and systemic resolution.
• Lead regional Quality Management Reviews and ensure accurate reporting and follow-up of quality metrics.

Cross-Functional Collaboration

• Partner with Product Supply Centers, Business Units, and regional teams to resolve cross-entity quality issues.
• Ensure compliance with intercompany Quality Assurance Agreements (QAAs).
• Drive cross-functional initiatives that improve quality performance and operational effectiveness.

Quality Culture & Capability

• Promote a strong culture of quality and continuous improvement.
• Provide guidance, coaching, and operational oversight to support consistent execution of QA activities.
• Deliver QMS and regulatory compliance training across the organization.
• Support the long-term QMS roadmap and global harmonization initiatives.

In this role, you will:

• Approve QMS documentation and quality records.
• Act as a Quality representative in audits, non-conformance reviews, and concessions.
• Serve as the local Quality Management Representative for certification activities.
• Authorize changes to the Quality Management System.
• Escalate systemic quality issues and ensure appropriate resolution.

What You Bring

Required Experience

• Significant experience in Quality Assurance or Regulatory Affairs within the medical device or pharmaceutical industry.
• Strong working knowledge of:
  
  • ISO 13485
  • EU MDR
  • MDSAP
  • US FDA QSR / QMSR
• Experience managing internal audits, CAPAs, document control, and non-conformances.
• Demonstrated experience with regional or multi-site QMS ownership.

Skills & Competencies

• Experience leading quality governance and management review processes.
• Ability to operate as a regional quality authority with decision-making responsibility.
• Strong analytical skills with experience using quality KPIs and performance metrics.
• Excellent communication and collaboration skills across global teams.
• Ability to train and influence stakeholders across the organization.
• Strong organizational skills and a structured, problem-solving mindset.

Education

• Bachelor's or higher degree in a scientific or technical field (or equivalent experience).

What we offer:

• Opportunity to work with a proactive and supportive team
• Excellent Medical, Dental and Vision coverage
• 401k, paid Vacation and Holiday
• A health of additional benefits including wellness reimbursement, tuition reimbursement and flexible spending account
• Opportunity to work on cutting edge in medical advancement
• Close-knit company culture
• Upward mobility

How to proceed?

We are looking forward to hearing from you! Apply by submitting your application and résumé in English, via the "Apply" button. Please note that we do not accept applications by e-mail.

EEO Statement

We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.

Here at Elekta, you will make a difference. We are a MedTech company that provides software and hardware to hospitals and clinics all over the world.

We have a responsibility toward our partners and customers to deliver solutions in a secure and sustainable way. Both when it comes to financial and environmental matters, but also for our employees to feel that they bring value, wherever in the organization they may work.

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.