Quality Assurance Engineer

Posted 2 Days Ago
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Crawley, West Sussex, England, GBR
In-Office
Mid level
Healthtech • Biotech
The Role
Maintain and improve the Quality Management System for medical device products. Lead quality/compliance activities, monitor metrics, conduct audits, investigate non-conformances, manage CAPA and root cause analyses, approve quality documentation, and partner with cross-functional teams to implement process improvements and ensure regulatory compliance.
Summary Generated by Built In
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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.

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)
     

Hiring process:
We are looking forward to hearing from you! Apply by submitting your application and résumé in English, via the “Apply” button.
For questions, please contact the Talent Acquisition Partner responsible, [email protected]. We do not accept applications through e-mail.
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.

Skills Required

  • Degree in Engineering or a related discipline, or equivalent industry experience (including formal engineering apprenticeship)
  • Experience in a Quality, Regulatory, or Engineering role within a regulated industry (medical devices preferred)
  • Knowledge of quality and regulatory standards such as ISO 13485, MDR, IEC, QSR, and MDSAP
  • Experience using quality improvement tools (CAPA, Root Cause Analysis, Lean, Six Sigma or similar)
  • Effective communication and stakeholder management skills; ability to work independently and collaboratively
  • Ability to interpret regulatory requirements and translate them into practical business solutions
  • Professional quality certifications (CQI, CQE, CQA or similar) and certified auditor training
  • Work from Crawley HQ four days per week (one day WFH)

Elekta Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elekta and has not been reviewed or approved by Elekta.

  • Retirement Support A 401(k) with employer match is a prominent benefit, with vesting noted as part of the plan.
  • Leave & Time Off Breadth PTO and paid holidays are included, with PTO accruing from the start and rollover allowed within limits.
  • Healthcare Strength Medical, dental, vision, life and disability coverage are included, complemented by an Employee Assistance Program.

Elekta Insights

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The Company
HQ: Stockholm
4,700 Employees
Year Founded: 1972

What We Do

At Elekta, our outcome-driven and cost-efficient solutions provide lasting clinical difference and are developed through sustainable environmental, social and governance practices. We’ve been working openly and proactively with clinicians and our partners for almost half a century to advance precision radiation therapy and meet continuously evolving patient needs—no matter where they are in the world. 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 120 countries and listed on Nasdaq Stockholm.

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