Quality Assurance Engineer

elekta; Veenendaal; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Profit-sharing plan

40 days paid time off

Monthly social gathering

Active employee association

Job summary

Elekta in the Netherlands is seeking a Quality Assurance Engineer to support process owners, implementing process and system changes that strengthen the local quality management system. You will work across Engineering, Regulatory Affairs, Sales, and Manufacturing to translate regulatory expectations into practical business requirements.

As an advocate for quality, you will contribute to compliant, efficient ways of working, participate in external audits, prepare audit plans and reports, and

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience in Quality, Regulatory Affairs or Engineering, preferably in a medical device environment.
• Knowledge of ISO 13485, ISO 14971, MDR/IVDR is preferred.

Responsibilities

• Contribute to projects and value streams to meet quality/regulatory requirements.
• Prepare monthly quality metrics and analyze data for improvement.
• Represent the organization in quality and operational processes and audits.

Skills

Quality management

Regulatory knowledge

Problem solving

Communication

Education

Bachelor's degree in Engineering

Tools

Lean Six Sigma

Quality tools

Job description

Quality Assurance Engineer

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.

What you will do at Elekta

As a Quality Assurance Engineer, you will support process owners in defining and implementing process and system changes that improve efficiency and strengthen the local quality management system. You will work across functions including Engineering, Order Fulfilment, Regulatory Affairs, Sales and Marketing, and Manufacturing. As an advocate for quality, you will help translate regulatory expectations into practical business requirements and contribute to compliant, effective ways of working.

Responsibilities

• Contribute to projects and value streams, helping ensure activities and deliverables meet applicable quality and regulatory requirements.
• Prepare monthly quality metrics for your area of responsibility and analyse process data and trends to identify opportunities for improvement.
• Represent the organisation in relevant quality and operational processes, such as corrective and preventive action, order fulfilment and manufacturing.
• Provide technical quality support to colleagues across Quality and other functions to help achieve business outcomes.
• Participate in external audits by regulatory authorities and support delivery of the internal audit plan.
• Prepare audit plans, conduct audits and produce clear audit reports, as applicable.
• Issue non-conformities and support timely, effective closure of identified actions.
• Support process and procedure changes, including review and authorisation of controlled documents and forms.
• Promote professional integrity, continuous improvement and adherence to Elekta values.

What you will bring

• A bachelor's degree in Engineering or a related field, or a formal engineering apprenticeship with demonstrated experience in a similar role.
• Experience in Quality, Regulatory Affairs or Engineering, preferably in a medical device environment.
• Training and practical knowledge of relevant medical device regulations and standards, such as ISO 13485, ISO 14971, ISO 14001, applicable IEC standards, MDD, MDR and US FDA quality system requirements.
• Ability to translate regulatory requirements into clear, meaningful business requirements.
• A structured approach to problem solving and familiarity with quality tools and techniques.
• Strong written and verbal communication skills, with the ability to collaborate effectively across functions and levels.
• Ability to work independently, manage priorities and deliver results within tight timelines.
• Fluency in English; additional language requirements may apply depending on the location.
• Quality-related professional certification is preferred.
• Experience with continuous improvement methods such as Lean, Six Sigma, design of experiments or statistical methods is an advantage.
• Willingness to travel when required.

What you will get

• Salary: A competitive salary, depending on your knowledge and experience.
• Bonus: You will take part in the local profit-sharing plan. On target, your gross annual bonus will be 10% of your gross annual salary.
• Benefits: We offer a variety of benefits, such as a monthly social gathering and a very active employee association.
• Time off: You will receive a total of 40 days of paid time-off per year.