Volumina Medical is a start-up and spin-off of the Swiss Federal Institute of Technology (EPFL), active in the field of medical devices. The company develops breakthrough innovations for plastic and reconstructive surgery, including an implantable biomaterial targeting regeneration of soft parts of the human body.
About the role
The Quality Engineer will support Quality and Regulatory Affairs, ensuring compliance of medical device development and maintaining a robust Quality Management System (QMS) for class III medical devices. The role involves driving Quality Assurance activities, supplier management, audits, and Design Control support, while promoting a strong quality culture across teams.
Key requirements
Engineering degree or Bachelor/Master in Sciences and/or Quality Assurance/Regulatory Affairs
3–5 years of experience in Quality Assurance in Pharma/Biotech/Medical Device industry
Strong knowledge of 21 CFR, MDR 2017/745, ISO 13485, ISO 14971
Proficiency in English and experience with QMS and Design Control
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