Senior Quality Investigation Engineer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78zqy2

ppIn this role you will lead and support Product Quality Complaint investigations for commercial and clinical products, working with manufacturing and regulatory teams worldwide.
You ensure investigations are scientifically sound and well documented within the PQC system, contributing to risk assessments and product safety.
You act as a key Product Quality Vigilance liaison for manufacturing sites and cross-functional partners across the product lifecycle.
You will drive improvements in investigation methods and knowledge transfer, supporting audits and regulatory requests.
This opportunity offers impact at scale within a global, collaborative environment focused on patient safety.
/pulliannual premio /liliparenteral leave (min 12 weeks) /liliinsurance plans /liliLead, conduct, and support end-to-end Product Quality Complaint investigations for Janssen products /liliCollaborate with Manufacturing Sites and cross-functional teams to ensure complete,



scientifically sound investigations /liliAct as SPOC for Product Quality Vigilance activities with sites and support training across sites /liliSupport failure investigations and Medical Device Reporting submissions /liliParticipate in signal and trend evaluations related to site products /liliPerform data-based risk management activities and decision-making /liliSupport complaint management transactions including DHR review and data handling /liliAssist with audits, inspections, and Health Authority requests /liliLead quality vigilance projects and support new business initiatives /liliProvide guidance on complaint handling requirements and SOPs /liliBachelor's degree in a technical, scientific, or engineering field /liliMinimum 5 years in Quality Assurance, Quality Control, Product Quality, or related quality function /liliExperience in pharmaceutical, medical device, or similarly regulated industry /liliExperience with complaint investigations, risk management, and quality systems /liliAbility to collaborate across functions and sites /liliKnowledge of applicable laws and standards (e.g., 21 CFR parts, ISO *****, ICH Q10, GMP/GVP) /li /ulpIn this role you will lead and support Product Quality Complaint investigations for commercial and clinical products, working with manufactu /p /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78zqy2