Quality Systems and Compliance Expert

2 days ago


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

You will act as functional support representing Quality as part of product development teams/projects.

Your focus will be on being the source of knowledge and expertise, bringing guidance and coaching/training on all aspects of Quality System Management and regulatory compliance.

You will also approve relevant documentation for cross-functional teams developing Software medical devices and health IT applications.

Key Responsibilities:

  • 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.


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