Are you a current Elekta employee?  

Please click here to apply through our internal career site Find Jobs - Elekta.

Want to join a team with a mission to improve and save lives?  

We continually look for motivated and skilled individuals who are interested in supporting our customers – healthcare professionals who use our products to help patients and their communities.

We currently have the following opportunity available - please contact us for more details!

We don’t just build technology. We build hope.
 

At Elekta we believe patients should have access to – and benefit from – precise, personalized radiation therapy. Bringing together science, technology, and clinical intelligence, we’re working towards the vision of a world where everyone has access to the best cancer care.

What you’ll do at Elekta

As a Senior Quality Assurance Engineer, you will act as functional support representing Quality as part of product development teams/projects. With a focus on being the source of knowledge and expertise, you bring guidance and coaching/training on all aspects of Quality System Management and regulatory compliance. You are also an approver of relevant documentation for cross-functional team developing Software medical devices and health IT applications.

This role includes compliance-related activities such as internal and external quality audits, nonconformance/concession/ CAPA management, training of the organization in the quality system, as well as improving and developing ways of working and QMS procedures together with other functions.

The right stuff

The Senior Quality Assurance Engineer´s responsibilities include (but are not limited to):

• Represent the Quality function in projects and processes.
• Responsible for promoting and where assigned, ensuring compliance to the quality management system and regulatory requirements.
• Responsible for escalation of possible compliance issues to the next level of the organization
• Collaborate closely and communicate effectively with other functional areas of the organization to meet business objectives ensuring regulatory compliance.
• Support processes organization as per agreed assignments
• Participate in the preparation and supporting external audits by coaching others, and/or as a guide and/or auditee.
• Participate in the preparation and performance of internal quality audits.
• Promote and maintain adherence to Elekta’s values.
• Responsible for decisions that impact the safety and effectiveness of products and services for their relevant area.

What you bring

To be able to be successful in the role as Senior Quality Assurance Engineer here at Elekta we think that you have:

• Experience and training in regulatory affairs, quality management systems and/or Engineering within a medical device environment.
• Training and/or experience in relevant medical device regulations and standards, e.g. EU MDR, QSR, ISO 13485, MDSAP, ISO 14971, IEC 62304
• A university degree in Engineering or equivalent in a related field.
• Experience in design and development and risk management, preferably including experience from projects involving medical device software.
• Strong English written and verbal communication skills. Able to work within a multicultural environment.
• High personal integrity, with an ability to interpret, adapt & provide guidance on regulations and translate into meaningful requirements to the business.
• Ability to generate collaborative spirit - An effective team player who prefers to share and communicate problems and solutions with other members of the team.
• Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.
• Possess a structured approach to problem-solving with an appreciation of quality tools & techniques.
• Understanding of SW development and agile way-of-working
• Availability for international travel
   

This is a wish list. If you don’t yet tick all the boxes, we’ll get there together. We’re looking for team players, forward thinkers, caring and daring colleagues who want to innovate and keep pioneering cancer care together with us.

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.

• Lunch Benefit
• Sport and culture benefit
• Occupational healthcare