Quality Engineer

Global market leader of quality and technology in medical radiation measurement is looking for a Quality Engineer to strengthen their team.

Your tasks:

Participation in the further development of the QM system for R&D (procedures, templates, methods, tools)
Verification of whether all normative and regulatory requirements for medical devices relevant for approval are met, including preparation and support of the conformity assessment procedure
Creation and maintenance of medical device files in accordance with MDR
Preparation and review of process-compliant documentation of development projects, as well as review implementation
Collaboration and implementation of usability and risk management activities
Participation in standard monitoring

What is required:

Good knowledge of MS-Office (Word, Excel)
Strong communication and team skills
Technical or scientific studies or many years of experience in the field of quality management
Very good German and English skills spoken and written
Knowledge of risk management (ISO 14971), software (IEC 62304), usability (IEC 62366-1/-2) and medical safety (IEC 60601 series) is advantage
Experience in quality management (ISO 13485) and in the international approval medical devices

What is offered:

Secure job in successful and expanding company
An attractive salary and variety of voluntary benefits
Interesting position with a great area of opportunities for development in medical technology
Great working atmosphere

Please apply with your CV or contact Dominika Wyrwinska for further details.

Email: dominika.wyrwinska@adaptivelifescience.com

#LI-DW1