Overview
In this role you will uphold and continuously improve Elekta’s Quality Management System to ensure our medical devices meet the highest quality, regulatory, and patient-safety standards. You will collaborate with cross-functional teams across procurement, manufacturing, regulatory affairs, and logistics to drive quality improvements and support audits. You’ll translate regulatory requirements into practical solutions and lead CAPA and non-conformance investigations to prevent recurrence. This position offers the chance to contribute to innovative healthcare technology that impacts patients globally, within a mission-driven, collaborative environment. A strong hook is Elekta’s commitment to “
Pay / Benefits
- Up to 25 paid vacation days (plus bank holidays)
- Holiday Purchase Scheme
- Private Medical Insurance
- Attractive Employer Pension Contribution Package
- Cycle to work scheme
- Life Assurance
Responsibilities
- Support and lead quality and compliance activities to project completion
- Monitor quality metrics, analyse trends, identify opportunities for continuous improvement
- Act as Quality representative in CAPA, Supply Chain Management, and Manufacturing
- Plan, conduct, and support internal and external audits and regulatory inspections
- Investigate non-conformances and drive corrective and preventive actions with root cause analysis
- Review and approve quality documentation, concessions, and procedures
- Partner with cross-functional teams to implement process improvements and maintain regulatory compliance
- Champion quality best practices and promote Elekta’s values across the organization
Key requirements
- Degree in Engineering or related discipline, or equivalent industry experience
- Experience in a Quality, Regulatory, or Engineering role within a regulated industry (medical devices preferred)
- Knowledge of ISO 13485, MDR, IEC, QSR, MDSAP
- Strong problem-solving with quality tools (CAPA, Root Cause Analysis, Lean, Six Sigma)
- Effective communication and stakeholder management; ability to work independently and collaboratively
- Ability to interpret regulatory requirements and translate them into practical solutions
- Professional quality certifications (CQI, CQE, CQA or similar) and auditor training is advantageous
- effective communication
- stakeholder management
- problem-solving
- ISO 13485
- MDR
- IEC
…