QE Engineer

Randstad Digital Italia; Pomezia; Ibrido; EUR 38.000 - 46.000; Tempo pieno

Vantaggi offerti da questo lavoro

Corporate welfare package

Professional development opportunities

Descrizione del lavoro

Randstad Digital Talent Services, a Randstad division, is partnering with a global leader in medical devices to hire a Quality Engineering Supervisor. You will lead a cross-functional team of Quality Engineers, Technicians and Inspectors, reporting to the Quality Manager.

The role encompasses GMP, ISO 13485/9001, FDA 21 CFR Part 820/211, EU MDR, MES/eQMS integration, NCR, CAPA, RCA, and data-driven KPI analytics, with a hybrid site in Pomezia near Rome.

Competenze

• Bachelor's or Master’s degree in Engineering is required.
• At least 5 years of experience in Quality Engineering within highly regulated industries (Medical Devices, SaMD, Healthcare, Pharma, or advanced manufacturing).
• At least 3 years of experience managing and leading teams.
• 3+ years of hands-on experience applying Lean methodologies, Supplier Quality frameworks, and problem-solving tools (FMEA, SPC, RCA).
• Proficiency in eQMS software, MES platforms, and BI/data analytics tools (Excel, Minitab, Power BI, Visio).
• Language: Professional working proficiency in English (written and spoken).

Mansioni

• Direct and mentor a multidisciplinary team of Quality Engineers, Technicians, Inspectors, and Data Quality Analysts.
• Track quality metrics using BI dashboards and data analytics.
• Oversee NCR through eQMS platforms and lead RCA and CAPA plans.
• Supervise incoming inspection and final QC testing integrated with MES.
• Drive Industry 4.0 initiatives in partnership with CI and Lean teams.
• Align manufacturing quality standards with Supplier Quality strategies and monitor vendor performance.
• Ensure full QMS compliance with cGMP standards (ISO 13485, ISO 9001, MDSAP, FDA 21 CFR Part 820/211, EU MDR).

Formazione

Bachelor's or Master’s degree in Engineering

Strumenti

eQMS software

MES platforms

Power BI

Minitab

Excel

Visio

Descrizione del lavoro

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 manufacturing)
• At least 3 years of experience managing and leading teams
• 3+ years of hands-on experience applying Lean methodologies, Supplier Quality frameworks, and problem-solving tools (FMEA, SPC, RCA)
• Technical & Digital Skills: Proficiency in eQMS software, MES platforms, and BI/data analytics tools (Excel, Minitab, Power BI, Visio)
• Language: Professional working proficiency in English (written and spoken)

Compensation & Benefits

• Location: Pomezia (Rome, Italy) with a hybrid work model
• Employment Type: Full-time, permanent position
• Salary Range: 38K€ – 46K€ (commensurate with experience)
• Benefits: Corporate welfare package, employee perks, and ongoing professional development opportunities

"This announcement is open to candidates of all genders (pursuant to Italian Law 903/77 and 125/91) and individuals of all ages and nationalities (Legislative Decree 215/03 and 216/03)."

"Please submit your resume with authorization for the processing of personal data (GDPR EU 2016/679)."