Quality Engineering Supervisor – Med Devices, Digital QA

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 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.