Sterility Assurance Specialist

Chi siamo

ENOVIS™

Enovis Corporation (NYSE: ENOV) è un'azienda in crescita nel settore delle tecnologie mediche orientata all'innovazione e dedicata allo sviluppo di soluzioni clinicamente differenziate che migliorano in modo misurabile i risultati dei pazienti e trasformano i flussi di lavoro. Grazie a una cultura del miglioramento continuo, al talento globale e all'innovazione, l'ampia gamma di prodotti, servizi e tecnologie integrate dell'azienda alimenta stili di vita attivi in ortopedia e non solo. Per ulteriori informazioni su Enovis, visitare il sito www.enovis.com.

Who We Are

ABOUT ENOVIS™

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

Di cosa ti occuperai | What You'll Do

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 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.

Qualifications & Experience

• Knowledge of processing and sterilization guidelines
• Drive for results
• Knowledge of ISO 13485, ISO 9001, QSR 21 CFR 820
• Education : 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 opportunità

Enovis 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

At Enovis, we are committed to providing equal employment opportunities to all individuals. Employment decisions are based solely on merit, qualifications, and the needs of the business. We uphold a policy of equal treatment for all employees and applicants, without discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, or any other characteristics unrelated to a person’s qualifications or job performance. This commitment extends to all aspects of employment, including recruitment, hiring, job assignments, compensation, training, promotion, demotion, transfers, layoffs, discipline, and separation, as well as all other terms and conditions of employment.