Quality Engineer, Medical Devices | Hybrid & Growth

Fresenius Medical Care AG; Palazzo Pignano; Hybrid; EUR 32.000 - 39.000; Vollzeit

Zusammenfassung

Fresenius Medical Care in Palazzo Pignano, Italy, is seeking a Quality/Manufacturing Engineer to drive problem solving, CAPA and process improvements within a regulated medical device environment.

You will collaborate with Manufacturing, Process Engineering, Regulatory Affairs and Quality teams, apply SPC and FMEA, and support audits and new product introductions.

The role requires a Bachelor's in engineering, 3 years in related field, Italian and English fluency, and willingness to travel.

Qualifikationen

• Bachelor's degree in Engineering or related technical discipline.
• Minimum 3 years of experience in Quality/Manufacturing/Process Engineering in a regulated environment.
• Medical device industry experience preferred.
• Experience with nonconformance management, CAPA, root cause investigations and corrective actions.
• Knowledge of Quality Management Systems; ISO 13485/14971 preferred.
• Experience using quality and statistical tools (SPC, MSA, Pareto).
• Strong analytical and data interpretation skills; cross-functional collaboration.
• Fluent in Italian and English; travel domestically and internationally may be required.

Aufgaben

• Investigate and resolve product, process and manufacturing quality issues using structured methodologies (8D, 5 Why, Fishbone, RCA).
• Support and execute CAPA, nonconformance, deviation, and corrective action activities per QMS.
• Analyze quality and manufacturing data to identify trends and opportunities for improvement.
• Provide technical support for customer complaints and collaborate with cross-functional teams to implement solutions.
• Apply statistical tools and data analysis to support decisions and process controls.
• Participate in continuous improvement initiatives focused on defect prevention and process robustness.
• Support new product introductions, design changes and technology transfers.
• Contribute to risk management activities including FMEA, control plans and quality planning.
• Coordinate with Manufacturing, Process Engineering, Operations, Regulatory Affairs and Quality teams; assist audits.

Kenntnisse

Quality engineering

CAPA

Root cause analysis

Statistical tools

Bilingual Italian/English

Manufacturing knowledge

Lean Six Sigma Green Belt

Ausbildung

Bachelor's degree in Engineering

Tools

Minitab

Jobbeschreibung

Fresenius Medical Care in Palazzo Pignano, Italy, is seeking a Quality/Manufacturing Engineer to drive problem solving, CAPA and process improvements within a regulated medical device environment.

You will collaborate with Manufacturing, Process Engineering, Regulatory Affairs and Quality teams, apply SPC and FMEA, and support audits and new product introductions.

The role requires a Bachelor's in engineering, 3 years in related field, Italian and English fluency, and willingness to travel.