Quality Assurance Engineer

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

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