Permanent / Based in Lausanne, Switzerland / Full time, 100%
Volumina Medical is a start-up, spin-off from EPFL (Ecole Polytechnique Fédérale de Lausanne), active in the field of implantable medical devices for reconstructive and plastic surgery. Since 2018, we develop cutting-edge injectable polymer- based biomaterials designed to reconstruct damaged tissues, e.g. after tumor ablation or due to aging.
The start-up Company is preparing for a growth phase, involving clinical activities as well as for market launch of its highly innovative lead product. In order to accompany this growth, we are looking for a highly motivated candidate to be responsible for the quality aspects of the product. The candidate will be in charge of the quality control activities of our semi- finished and finished products (GMP manufacturing of class 3 medical devices), and of some quality assurance activities.
- Lead and perform quality control testing of semi-finished and finished products (physico-chemical properties, involving analytical techniques such as pH, mechanical properties measurement, microscopy, HPLC, GPC, ...)
- Lead and perform incoming inspection of raw materials and consumables used in manufacturing
- Lead and perform environmental monitoring of the clean room
- Identify and develop relevant new analytical techniques for improving the control of the quality of the product
- Participate to the improvement and (re-)validation of quality control methods
- Be responsible for the management of quality control samples and manage the interactions with external service
providers in a timely manner
- Record and communicate quality control results to the production team and to management
- Manage all documents related to his/her activities following the quality sytem of the Company
- Participate to development and/or validation projects as quality referee
- Manage non-conformities related to his/her activities
- Manage one or two quality assurance process(es)