Senior Quality Investigation Engineer
Pubblicato il 31-07-2026 - Experteer Italy in Latina
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 13485, 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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