Senior Quality Assurance Engineer
4 ore fa
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.
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vicenza, Italia Officina Stellare S.p.A A tempo pienoQUALITY ASSURANCE ENGINEER – ABOUT THE ROLE Officina Stellare is looking for a Quality Assurance professional to join the Quality Department. The selected candidate will work closely with the Quality Manager and Process Owner to ensure the company’s Quality Management System complies with UNI EN 9100:2018 standards, guaranteeing the conformity of...
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Vicenza, Italia Officina Stellare S.p.A A tempo pienoQUALITY ASSURANCE ENGINEER – ABOUT THE ROLE Officina Stellare is looking for a Quality Assurance professional to join the Quality Department. The selected candidate will work closely with the Quality Manager and Process Owner to ensure the company’s Quality Management System complies with UNI EN 9100:2018 standards, guaranteeing the conformity of...
