About Cellex
Tutti i potenziali candidati sono incoraggiati a leggere l'intera descrizione del lavoro prima di candidarsi.
Cellex is an innovative Italian SME designing and developing bioreactors for advanced cell culture and tissue engineering applications, working with international stakeholders and customers.
Role overview
We 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). xjrgpwk
Opportunity to have real impact by contributing to the evolution of the QMS and compliance roadmap.