Descrizione:
ENOVIS™
Who We AreABOUT ENOVIS™
Di 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.
- Be responsible of gamma, beta irradiation and ETO sterilization validation within enovis Italy
- Ensure 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 validation
- Evaluate instruments and formally document the decision regarding their suitability for cleaning, disinfection and sterilization, or carry out the appropriate validation
- Evaluating design and/or process changes regarding their impact on sterility, and reprocessing
- Reviewing the results of all tests related to product cleanliness; performing OOS investigations
- Conducting trainings in the areas of hygiene, product cleanliness and sterility
- Participation in audits as a Subject Matter Expert
- Embrace and share the culture of the information security and personal data protection.
- Technical Bachelor/Master Degree within life sciences or medical technology
- In 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
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