Quality Assurance Engineer

Elekta AB; Crawley; Sur place; GBP 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

25 days holiday + bank holidays

Private Medical Insurance

Employer Pension Contribution

Résumé du poste

Elekta AB is seeking a Quality Assurance Engineer to maintain and improve the Quality Management System, ensuring products meet high standards of quality, compliance and patient safety. You will work with Procurement, Supply Chain, Manufacturing, Regulatory Affairs and Logistics to drive improvements.

You’ll support audits, regulatory inspections, and translate requirements into practical business solutions across global teams.

Qualifications

• Degree in Engineering or equivalent industry experience.
• Experience in quality/regulatory roles in regulated industries, ideally medical devices.
• Knowledge of ISO 13485, MDR, IEC, QSR, MDSAP.
• Strong problem-solving with CAPA/Root Cause/Lean Six Sigma.

Responsabilités

• Lead quality and compliance activities to ensure projects are delivered.
• Monitor quality metrics, analyse trends, identify improvement opportunities.
• Act as Quality representative in CAPA, SCM, and Manufacturing processes.

Connaissances

Quality assurance

Regulatory compliance

CAPA

Root cause analysis

Lean Six Sigma

Cross-functional collaboration

Communication

Independent / team work

Formation

Engineering degree

Engineering apprenticeship

Outils

CAPA system

Audit tools

Description du poste

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

• 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)
• Work Pattern (you are required to work from the Crawley HQ 4 days a week with 1-day WFH)

We are an equal opportunity employer.

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.

We don't just build technology. We build hope for everyone dealing with Cancer. Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com.

About Elekta As a leader in precision radiation therapy, Elekta is committed to ensuring every patient has access to the best cancer care possible. We openly collaborate with customers to advance sustainable, outcome-driven and cost-efficient solutions to meet evolving patient needs, improve lives and bring hope to everyone dealing with cancer. To us, it's personal, and our global team of 4,700 employees combine passion, science, and imagination to profoundly change cancer care. We don't just build technology, we build hope. Elekta is headquartered in Stockholm, Sweden, with offices in more than 120 countries and listed on Nasdaq Stockholm. For more information, visit elekta.com or follow us on LinkedIn, Glassdoor, Twitter, Facebook, Instagram and YouTube.