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Quality Junior Specialist - cat. protetta (l.68/99)

Hartmann Foromed Srl

Hartmann Italy, the Italian branch of Hartmann Group (German health care listed company), is looking for a young talent to be included in the Quality Team, based in our offices in Caivano (Naples).
The colleague will support the team with particular focus on:
• In collaboration with the Quality Assurance Manager, support and ensure the maintenance and the updating of the Quality System Management and of all the regulatory requirements, supporting the Manager in the preparation and implementation of the documents necessary for the QSM;
• Promotes the corrective actions necessary to avoid non-conformities, verifying the implementation of the solutions adopted, periodically carrying out the review;
• Promotes the preventive actions necessary to ensure compliance of products and processes with the ISO 13485 and UNI ISO 9001 standards;
• Ensure that every sterilized medical device is produced and checked in strict compliance with the laws, harmonized standards, Good Manufacturing Standards (GMP) and what is established in the approved dossiers;
• Contribute in carrying out quality checks in the sterilized “white room” and in the warehouse areas on a daily basis;
• Collaborate with external laboratories during checks in the company and during the validation of the sterilization unit
• Participate in agreements relating to the assessment of the reliability of suppliers, the definition of the characteristics of raw materials and materials and the activities to be carried out to accept or return such materials;
• Participate in the final control process of the finished products and in the release process in production and with the suppliers;
• Be involved in the return workflow preparing returns information to be sent to Headquarter or to external suppliers.

Il Gruppo HARTMANN è uno dei principali provider a livello mondiale di prodotti medicali e per l’igiene della persona. La forza del Gruppo HARTMANN risiede nelle forti competenze maturate nel corso di più di 200 anni di storia nel campo del trattamento delle ferite, della gestione dell’incontinenza, dell’autodiagnosi, della prevenzione delle infezioni e dei rischi in sala operatoria.