Quality Assurance Engineer: Elekta

Manor Royal Business District; Crawley; Hybrid; GBP 42,000 - 62,000; Full time

Benefits offered by this job

In-office 4 days/wk

WFH option

25 days vacation

Holiday purchase scheme

Private medical insurance

Pension plan

Cycle to work

Life assurance

Onsite restaurant

Job summary

Elekta, a global leader in cancer care technology, is seeking a Quality Assurance Engineer to safeguard our Quality Management System. You’ll collaborate with Procurement, Supply Chain, Manufacturing, Regulatory Affairs and Logistics to ensure top quality and patient safety across products and processes.

You will champion CAPA, audits, and regulatory inspections, translating standards into practical business solutions while driving continuous improvement in a regulated healthcare environment.

Qualifications

• Degree in Engineering or related field or equivalent industry experience.
• Experience in a regulated industry, preferably medical devices.
• Knowledge of quality/regulatory standards: ISO 13485, MDR, IEC, QSR, and MDSAP.
• Strong problem-solving using CAPA, root-cause analysis, lean, Six Sigma or similar methods.

Responsibilities

• Support and lead quality and compliance activities across projects.
• Monitor quality metrics, analyze trends, and identify improvement opportunities.
• Act as quality representative in CAPA, SCM, and Manufacturing processes.
• Plan, conduct and support internal/external audits and regulatory inspections.
• Investigate non-conformances and drive corrective and preventive actions.
• Review and approve quality documentation and related records.
• Collaborate with cross-functional teams to implement process improvements and maintain compliance.
• Promote quality best practices and Elekta values across the organization.

Skills

Quality assurance

Regulatory compliance

CAPA

Root cause analysis

Lean Six Sigma

ISO 13485

MDR

MDSAP

Communication

Stakeholder management

Education

Engineering degree

Job description

We don’t just build technology. We build hope for everyone dealing with Cancer.

At Elekta, we believe every individual deserves access to the best cancer care. That’s why we’re committed to developing innovative solutions that make precision radiation therapy and radiosurgery more effective, efficient, and accessible. If you're passionate about making a meaningful impact, we invite you to bring your expertise and energy to our team.

What You’ll Do At Elekta:

As a Quality Assurance Engineer at Elekta, you'll play a key role in maintaining and continuously improving our Quality Management System, helping ensure our products and processes meet the highest standards of quality, compliance, and patient safety.

Working closely with teams across Procurement, Supply Chain, Manufacturing, Regulatory Affairs, and Logistics, you'll drive quality improvements, support audits and compliance activities, and help translate regulatory requirements into practical business solutions. Your work will directly contribute to delivering innovative healthcare technology that improves the lives of patients around the world.

Responsibilities:

• Support and lead quality and compliance activities, ensuring projects are delivered to completion.
• Monitor quality metrics, analyse trends, and identify opportunities for continuous improvement.
• Act as a Quality representative within key processes, including CAPA, Supply Chain Management, and Manufacturing.
• Plan, conduct, and support internal audits, external audits, and regulatory inspections.
• Investigate non-conformances and support the implementation and closure of corrective and preventive actions including root cause analysis.
• Review and approve quality documentation, concessions, procedures, and related records.
• Partner with cross-functional teams to implement process improvements and maintain regulatory compliance.
• Champion quality best practices and promote Elekta's values across the organisation.

What You’ll Bring:

• Degree in Engineering, a related discipline, or equivalent industry experience, including a formal engineering apprenticeship.
• Experience in a Quality, Regulatory, or Engineering role within a regulated industry, ideally medical devices.
• Knowledge of relevant quality and regulatory standards, such as ISO 13485, MDR, IEC, QSR, and MDSAP.
• Strong problem-solving skills with experience using quality improvement tools such as CAPA, Root Cause Analysis, Lean, Six Sigma, or similar methodologies.
• Effective communication and stakeholder management skills, with the ability to influence and collaborate across teams. Able to work both independently and collaboratively, while prioritising workload in line with business needs.
• Ability to interpret regulatory requirements and translate them into practical business solutions.
• Professional quality certifications (CQI, CQE, CQA or similar) and certified auditor training would be advantageous.

What You’ll Get:

In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. In addition to this, Elekta offers a range of benefits.

• Work Pattern (you are required to work from the Crawley HQ 4 days a week with 1-day WFH)
• 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
• Onsite subsidized restaurant, offering budget-friendly dining
• Love electric (Electric vehicle salary sacrifice scheme)

We are an equal opportunity employer

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