02 ott - Pomezia
Randstad Digital Italia
Randstad Digital Talent Services, a specialized division of Randstad dedicated to recruiting high-caliber IT and technology professionals, is partnering with a global leader in medical devices and healthcare services to hire a Quality Engineering Supervisor.
Role Overview
Reporting directly to the Quality Manager, the Quality Engineering Supervisor will lead a cross-functional team of Quality Engineers, Technicians, and Inspectors. This role bridges core operational and regulatory compliance (GMP, ISO 13485, ISO 9001, FDA 21 CFR Part 820/211, EU MDR) with digital quality initiatives, including MES/eQMS integration, Non-Conformance Resolution (NCR), CAPA management, and Business Intelligence-driven KPI analytics.
Key Responsibilities
- Direct and mentor a multidisciplinary team (Quality Engineers, Technicians, Inspectors, and Data Quality Analysts), setting performance goals, managing workloads, and driving professional development
- Track internal and customer-facing quality metrics (DPU - Defects Per Unit, FPY- First Pass Yield) using BI dashboards and advanced data analytics
- Oversee non-conformities (NCR) through eQMS platforms, leading Root Cause Analysis (RCA) and corrective/preventive action plans
- Supervise incoming inspection and final QC testing activities integrated with plant manufacturing execution systems (MES)
- Digitalization & Continuous Improvement: Drive the transition toward Industry 4.0 in close partnership with Continuous Improvement and Lean teams
- Align manufacturing quality standards with broader Supplier Quality strategies and monitor vendor performance
- Ensure full Quality Management System (QMS) compliance with cGMP regulatory standards (ISO 13485, ISO 9001, MDSAP, FDA 21 CFR Part 820/211, EU MDR)
Requirements & Qualifications
- Bachelor's or Master's degree in Engineering (required)
- At least 5 years of experience in Quality Engineering within highly regulated industries (Medical Devices, SaMD, Healthcare, Pharma, or advanced man
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