Quality Engineer, Medical Devices | Hybrid Italy

Fresenius Medical Care AG; Palazzo Pignano; Híbrido; EUR 32.000 - 39.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care AG seeks a Quality Engineer at Palazzo Pignano, Italy, with a hybrid work model. You will drive quality improvements, lead CAPA activities, and collaborate with Manufacturing, Process Engineering and Regulatory teams to ensure ISO 13485 compliance.

Ideal candidates will have 3+ years in quality roles, fluent Italian and English, strong data skills (Minitab preferred) and a readiness to travel as needed.

Formación

• Bachelor's degree in Engineering or related technical field.
• Minimum 3 years in Quality/Manufacturing/Process Engineering in a regulated environment.
• Experience in nonconformance, CAPA, investigations and corrective actions.
• Knowledge of ISO 13485 and ISO 14971 preferred; fluent in Italian and English.

Responsabilidades

• Investigate and resolve product, process, and manufacturing quality issues using structured methods.
• Support CAPA, nonconformance, deviation and corrective action activities per QMS.
• Analyze quality data to identify trends and opportunities for improvement.
• Provide technical support for customer complaints and collaborate with cross-functional teams.
• Apply SPC, process capability, Pareto and MSA to support data-driven decisions.
• Participate in continuous improvement and new product/tech transfers.
• Assist in risk management activities including FMEA and validation.

Conocimientos

CAPA processes

Root cause analysis

Data interpretation

Quality tools

Analytical skills

Cross-functional collab

Minitab

Educación

Bachelor's degree in Engineering

Herramientas

Minitab

MS Office

Descripción del empleo

Fresenius Medical Care AG seeks a Quality Engineer at Palazzo Pignano, Italy, with a hybrid work model. You will drive quality improvements, lead CAPA activities, and collaborate with Manufacturing, Process Engineering and Regulatory teams to ensure ISO 13485 compliance.

Ideal candidates will have 3+ years in quality roles, fluent Italian and English, strong data skills (Minitab preferred) and a readiness to travel as needed.