Senior quality engineer

1 giorno fa


WorkFromHome, Italia Adecco A tempo pieno

La divisione specializzata Adecco LifeScience ricerca, per conto di nota azienda operante nel settore Medicale, di un/a: Senior Quality Assurance Engineer La figura avrà la responsabilità di garantire la conformità dei processi e dei prodotti alle normative di riferimento, supportando sia lo sviluppo di nuovi prodotti sia le attività di produzione. Responsabilità principali Gestione dei processi di Change Control, CAPA e Deviations. Conduzione di audit interni ed esterni, inclusi audit a fornitori e distributori. Supporto a indagini, analisi delle cause radice e implementazione di azioni correttive/preventive. Revisione QA di procedure, protocolli tecnici, validazioni e report. Partecipazione alla definizione dei requisiti di progetto e alla validazione/verifica delle esigenze cliente. Facilitazione del processo di Risk Management secondo ISO 14971. Definizione e gestione di procedure per la raccolta e analisi dei dati di processo e qualità. Supporto alle attività di validazione di processo e ricalibrazione periodica delle attrezzature critiche. Esecuzione di gap analysis rispetto a normative e standard di settore, con conseguente piano di miglioramento. Attività di training come Subject Matter Expert per il team QA. Gestione di attività di rilascio prodotto e supporto a field action e processi di recall. Requisiti obbligatori Laurea in Biotecnologie Industriali, Chimica, Ingegneria dei Biomateriali, Ingegneria Biomedica o discipline affini. Almeno 3 anni di esperienza in ruoli di Quality Assurance/Quality Engineering. Conoscenza approfondita di ISO 13485, ISO 14971, GMP, QSR, MDR ed eventuali normative FDA (21 CFR). Esperienza nella gestione di audit interni/esterni e con fornitori. Conoscenza delle metodologie di Statistical Process Control. Ottima padronanza della lingua inglese. Competenze informatiche su MS Office, database e sistemi di gestione qualità elettronici (eQMS). Cosa offriamo Contratto CCNL Chimico-Farmaceutico. Possibilità di lavoro in modalità smart working (un giorno a settimana). Buoni pasto e welfare aziendale. Opportunità di crescita professionale in un contesto internazionale e innovativo. #J-18808-Ljbffr



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