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Quality Assurance Specialist, Elekta

Elekta is now looking for a Quality Assurance Specialist to fill an interesting role in the organization. This opportunity is well suited for a person who wants to improve, support and drive quality system processes and related governance activities.

The Role

Your key responsibilities will be following:

  • Support the implementation of Elekta Quality Policy, other directives and processes throughout the Elekta Solutions quality system and organization
  • Promote the quality system and its principles throughout the organization.
  • Suggest and implement quality related process improvements
  • Quality KPI monitoring and gathering
  • Manage and perform internal audits
  • Support external audits preparations and participate
  • Support quality system non-conformities handling including local CAPAs
  • Training of the organization in the quality system.
  • Support activities/projects in accordance with the RA & Q overall business plan and in alignment with the overall business objective

The role is in Elektas head office in Stockholm.

Elekta can offer you a global environment where quality assurance is highly valued. You will be a part of a motivated team where you will have the ability to influence the development of the company as well as your own career.

Background and personal qualities

To be successful in this role you need to have a university degree from a pertinent field such as mechanical, industrial, electrical engineering or equivalent area. You also have experience from quality work within the medical device industry. You have performed internal audits and are acquainted with external audits. You have a good knowledge of the European Regulations for Medical Devices (MDD/MDR), MDSAP, US FDA legislation and related harmonized ISO standards. Experience from acting in a global organization or within design and manufacture would be of advantage.

You have excellent English, both orally and written.

Highly valued personal qualifications and competencies are as following:

  • Confident and open personality who can communicate effectively, both written and orally with people at all levels
  • Administrative skills and capable of producing results working unsupervised under own initiative
  • A structured/organized approach to problem solving with an appreciation of quality tools & techniques
  • An effective team player who prefers to share and communicate problems and solutions with other members of the team
  • Confident and open personality who can communicate effectively, both written and orally with people at all levels
  • A positive attitude towards change to promote the global goals of the business.

Application

In this process Elekta is working with Level Recruitment. To apply, please visit www.levelrecruitment.se and click on “Ansök här”. If you have any questions, please contact Louisa Torstensson at 08-120 50 423.

Sökord: RA, Regulatory Affairs, QA, quality assurance, quality management, medical devices, MDD, MDR, QMS, quality management system

Om företaget
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both healthcare providers and patients, Elekta aims to improve, prolong and even save patient lives. Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide with 100,000 patients annually receiving diagnosis, treatment or follow-up facilitated by Elekta solutions.

Kontaktperson Louisa Torstensson 08-120 50 423
Tjänstens omfattning Heltid Anställningsform Tillsvidare Placeringsort STOCKHOLM
Om företaget
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both healthcare providers and patients, Elekta aims to improve, prolong and even save patient lives. Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide with 100,000 patients annually receiving diagnosis, treatment or follow-up facilitated by Elekta solutions.

Quality Assurance Specialist, Elekta

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