Chi siamoENOVISTMWho We AreABOUT ENOVISTMDi cosa ti occuperai | What You'll DoFor our offices in San Daniele del Friuli (UD), Italy, we are currently seeking a Sterility Assurance Specialist to join our Quality Assurance team.Job Purpose
Planning, performing, and evaluating sterilization validations and revalidations for gamma, beta irradiation and ETO sterilization (e.g., dose establishing, dose audits, dose mapping, MPQ, PPQ).Planning, performing, and evaluating validations for the reprocessing of instruments (cleaning, disinfection, sterilization).Planning and evaluating monitoring tests on products, clean rooms, and water, conducted to demonstrate the cleanliness of final products.
Major Accountabilities
Be responsible of gamma, beta irradiation and ETO sterilization validation within enovis ItalyEnsure that all activities associated with gamma, beta and ETO sterilization including the maintenance of the product families and process categories are carried out.Evaluate new products and formally document the decision regarding their assignment to a gamma and/or beta irradiation and/or ETO product family respectively process category, or carry out the appropriate validationEvaluate instruments and formally document the decision regarding their suitability for cleaning, disinfection and sterilization, or carry out the appropriate validationEvaluating design and/or process changes regarding their impact on sterility, and reprocessingReviewing the results of all tests related to product cleanliness; performing OOS investigationsConducting trainings in the areas of hygiene, product cleanliness and sterilityParticipation in audits as a Subject Matter ExpertEmbrace and share the culture of the information security and personal data protection.
Education and Experience
Technical Bachelor/Master Degree within life sciences or medical technologyIn alternative completed apprenticeship and 5 years of professional experience in the field of medical devices or microbiological laboratory
Experience : At least 1 year experience in quality assurance.Dichiarazione di pari opportunitàEnovis si impegna a garantire pari opportunità di lavoro a tutti. Le decisioni relative all'assunzione si basano esclusivamente sul merito, sulle qualifiche e sulle esigenze aziendali. Applichiamo una politica di parità di trattamento per tutti i dipendenti e i candidati, senza discriminazioni basate su razza, colore della pelle, religione, nazionalità, sesso, orientamento sessuale, identità di genere, età, status di veterano, disabilità o qualsiasi altra caratteristica non correlata alle qualifiche o alle prestazioni lavorative di una persona. Questo impegno si estende a tutti gli aspetti dell'occupazione, tra cui reclutamento, assunzione, assegnazione dei compiti, retribuzione, formazione, promozione, retrocessione, trasferimenti, licenziamenti, provvedimenti disciplinari e cessazione del rapporto di lavoro, nonché a tutti gli altri termini e condizioni di impiego.EOE AA M/F/VET/Disability Statement#J-18808-Ljbffr