Quality Engineer

Quality Engineer

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

Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations.

As a Quality Engineer, you will play a key role in ensuring product quality, process reliability, and compliance within our manufacturing environment. You will investigate quality issues, support corrective and preventive actions, analyze manufacturing data, and drive continuous improvement initiatives. Working closely with cross-functional teams, you will help maintain high quality standards while supporting innovation, operational excellence, and patient safety throughout the product lifecycle.

Your 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.

Your Profile:

• 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, including SPC, process capability analysis, Pareto analysis, and trend analysis.

• 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.

• Experience with process validation, equipment qualification, manufacturing transfers, extrusion, injection molding, automation, or assembly processes is preferred.

• Proficiency in Microsoft Office applications and statistical software (Minitab preferred).

• Willingness to travel domestically and internationally as required.

• Based in Vršac or willing to relocate.

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
• The benefits of a successful global corporation with the collegial culture of a medium-sized company