Tensive is a biomedical startup developing innovative prostheses aiming to offer a natural breast reconstruction or augmentation to improve patients' quality of life. The production team is looking for a Production Specialist to support production and quality control activities.
We love to hire collaborative people with a passion for learning and a teamwork spirit. Our team invests heavily in coaching new hires.
ResponsibilitiesPerforms manufacturing activities in ISO 7 cleanroom for Class III medical devices;Perform quality control tests on the production intermediates and the final product according to the internal procedures and applicable standards;Participates in the management of non-conformities, including drafting of the appropriate reports, investigation of root causes, implementation of preventive and corrective actions, and drafting related documents;Participates in the risk assessments of the manufacturing process, and validation of the manufacturing process;Performs installation qualification, operation qualification, and performance qualification of equipment involved in production;Participates in the monitoring of the environmental conditions and parameters of the cleanroom;Performs ordinary and extraordinary maintenance of equipment;Performs cleaning of the equipment, cleanroom, fills and updates the related registers;Fills and updates production templates, records, registries, and documentation;Drafts and updates the Standard Operating Procedures (SOPs) and operating instructions (WIs) of the company's production process;Verifies the state of maintenance and calibration of production equipment;Checks the maintenance and calibration status of instruments used in production;RequirementsPrevious work experience in the production of medical devices class III or the pharmaceutical field and knowledge of quality management systems is encouraged and will be positively evaluated.Technical Diploma or Bachelor's degree in scientific or technical disciplines;The candidate must be willing to work in a controlled cleanroom environment, which involves the wearing of relevant clothing and personal protective equipment;The candidate must be willing to work on a 2-shift basis;Knowledge of organizational, operational, and technical aspects of the production of medical devices or pharmaceutical products;Good knowledge of the English language, spoken and written;Good knowledge of the Microsoft Office package.
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