Senior Quality Assurance Engineer Role

3 days ago


Helsinki, Uusimaa, Finland Elekta Full time
Our Mission
At Elekta, we strive to provide hope for everyone dealing with cancer. Our goal is to offer the best possible cancer care worldwide.

About the Role
We are seeking a Senior Quality Assurance Engineer to join our Regulatory Affairs & Quality Team in Helsinki. As a member of this team, you will be responsible for ensuring compliance to the quality management system and regulatory requirements.

Key Responsibilities
- Represent the Quality function in projects and processes
- Promote and ensure compliance to the quality management system and regulatory requirements
- Escalate possible compliance issues to the next level of the organization

Requirements
- 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

Why Join Us?
In this role, you will have the opportunity to work on challenging projects, collaborate with a global team, and contribute to the development of innovative medical devices. We offer a dynamic and supportive work environment, flexible working arrangements, and opportunities for professional growth and development.

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