Quality Engineer

Fresenius Medical Care AG; Palazzo Pignano; Hybrid; EUR 32,000 - 39,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality engineering

CAPA

Root cause analysis

Statistical tools

Bilingual Italian/English

Manufacturing knowledge

Lean Six Sigma Green Belt

Education

Bachelor's degree in Engineering

Tools

Minitab

Job description

Working mode: Hybrid

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 employees.

Location: Palazzo Pignano (CR)

Working mode: Hybrid

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.

Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation

At our Palazzo Pignano plant in Italy, we focus on the production of high-quality components used in dialysis therapy, including bloodlines, tubing systems, and accessories. With a dedicated team of more than 550 employees, our facility utilizes advanced technologies such as bloodline assembly, automated sub-assembly, extrusion, injection molding, and sterilization. This site plays a vital role in Fresenius Medical Care’s commitment to enhancing patient care worldwide. Join our passionate team and be part of this global impact!

Key Responsibilities

• Investigate and resolve product, process, and manufacturing quality issues using structured problem-solving methodologies such as 8D, 5 Why, Fishbone, and Root Cause Analysis.
• Support and execute CAPA, nonconformance, deviation, and corrective action activities in compliance with the Quality Management System.
• Analyze quality and manufacturing data to identify trends, process variation, recurring issues, and opportunities for improvement.
• Provide technical support for customer complaint investigations and collaborate with cross-functional teams to determine root causes and implement effective solutions.
• Apply statistical quality tools such as SPC, process capability analysis, Pareto analysis, trend analysis, and measurement system analysis to support data-driven decision‑making.
• Participate in continuous improvement initiatives focused on defect prevention, process robustness, variation reduction, and operational excellence.
• Support new product introductions, design changes, process improvements, technology transfers, and manufacturing transfer projects.
• Contribute to risk management activities, including FMEA, process controls, validation activities, and quality planning.
• Collaborate closely with Manufacturing, Process Engineering, Operations, Supply Chain, Regulatory Affairs, and Quality teams to improve product and process performance.
• Ensure compliance with applicable quality standards and regulatory requirements, including ISO 13485 and ISO 14971.
• Support internal and external audits by providing technical documentation, investigation records, and quality evidence.
• Promote best practices and knowledge sharing across manufacturing sites to support standardized quality engineering processes.

Required Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical & Electronics Engineering, Chemical Engineering, Industrial Engineering, Materials Science, or a related technical discipline,
• Minimum 3 years of experience in Quality Engineering, Manufacturing Engineering, Process Engineering, or a related role within a regulated manufacturing environment,
• Medical device industry experience is preferred,
• Experience with nonconformance management, CAPA processes, root cause analysis, investigations, and corrective actions,
• Knowledge of Quality Management Systems and quality engineering principles. Familiarity with ISO 13485 and ISO 14971 is preferred,
• Experience using quality and statistical tools,
• Strong analytical, problem-solving, and data interpretation skills,
• Excellent communication and cross-functional collaboration abilities,
• Lean Six Sigma Green Belt certification or equivalent experience is considered an asset,
• Fluent in Italian and English.
• Proficiency in Microsoft Office applications and statistical software (Minitab preferred).
• Willingness to travel domestically and internationally as required,

OUR OFFER FOR YOU

There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.

• Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
• A large number of committed people with a wide range of skills, talents and experience
• This role starts within a minimum annual gross salary benchmark of €35.000, in accordance with applicable transparency regulations. The final offer will be determined based on experience, skills, and internal equity.