About CellexCellex is an innovative Italian SME designing and developing bioreactors for advanced cell culture and tissue engineering applications, working with international stakeholders and customers.Role overviewWe are looking for a detail-oriented Junior Quality Engineer to support the maintenance and growth of our Quality Management System and to contribute to broader compliance and certification/regulatory milestones (beyond routine maintenance).Key responsibilities- Support QMS operations: document control, templates, record keeping, training records, periodic reviews.- Support audit readiness: evidence collection, action tracking, internal audit preparation and follow-up.- Support nonconformities / CAPA: logging, root-cause support, effectiveness checks (as applicable).- Support supplier quality activities: documentation checks, basic qualification records, follow-ups.- Contribute to QMS digitalization (QMS software / eQMS tools) where applicable.- Assist in preparing quality/regulatory documentation aligned with future company milestones (e.G., additional management system certifications and product compliance pathways).- Support administrative tasks, including but not limited to office management and contract-related activities.- Requirements (must-have)- MSc degree (preferably Engineering;
Biomedical/Industrial/Management Engineering are a plus).- Strong proficiency with Microsoft Office, especially Excel (tables, pivoting, data checks, structured reporting).- Strong attention to detail, accuracy, and a structured mindset.- Good English (written and spoken).Nice-to-have- Familiarity with ISO 9001 / ISO 14001 principles or other ISO management system standards.- Exposure to medical device compliance / CE marking (EU MDR awareness is a plus).- Familiarity with QMS software (eQMS, document management tools, trackers).What we offer- Young, technical, hands-on environment in an innovative BioTech SME.- Hybrid work (1 day/week remote).- Competitive compensation package (details discussed during the process).- Opportunity to have real impact by contributing to the evolution of the QMS and compliance roadmap.