Senior Quality Investigation Engineer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78vh7f

In 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.
annual premio
parenteral leave (min 12 weeks)
insurance plans
Lead, conduct, and support end-to-end Product Quality Complaint investigations for Janssen products
Collaborate with Manufacturing Sites and cross-functional teams to ensure complete, scientifically sound investigations
Act as SPOC for Product Quality Vigilance activities with sites and support training across sites
Support failure investigations and Medical Device Reporting submissions




Participate in signal and trend evaluations related to site products
Perform data-based risk management activities and decision-making
Support complaint management transactions including DHR review and data handling
Assist with audits, inspections, and Health Authority requests
Lead quality vigilance projects and support new business initiatives
Provide guidance on complaint handling requirements and SOPs
Bachelor's degree in a technical, scientific, or engineering field
Minimum 5 years in Quality Assurance, Quality Control, Product Quality, or related quality function
Experience in pharmaceutical, medical device, or similarly regulated industry
Experience with complaint investigations, risk management, and quality systems
Ability to collaborate across functions and sites
Knowledge of applicable laws and standards (e.g., 21 CFR parts, ISO *****, ICH Q10, GMP/GVP)
In this role you will lead and support Product Quality Complaint investigations for commercial and clinical products, working with manufactu
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78vh7f