Quality Systems Engineer and Regulatory Expert

6 days ago


Helsinki, Uusimaa, Finland Elekta AB (publ). Full time

We're seeking a highly skilled Quality Systems Engineer and Regulatory Expert to join our team at Elekta AB (publ.). This role is part of our driven global team, where we aim to attract and invite the best competences to deliver software and hardware solutions in a secure and sustainable way.

In this exciting and diverse role, you will represent Quality on internal management meetings, projects, analysing and preparing responses on governing agency actions. As a Quality Systems Engineer and Regulatory Expert, you will be responsible for promoting and ensuring compliance to the quality management system and regulatory requirements.

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.

Accountabilities
  • Responsible for promoting and ensuring compliance to the quality management system and regulatory requirements.
  • Collaborate closely and communicate effectively with other functional areas of the organization to meet business objectives ensuring regulatory compliance.


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