Quality Management Engineer (Medical Devices)

About Us

Lmb SOFT d.o.o., based in Niš, Serbia, is the production and development site of Lmb Technologie GmbH in Schwaig, Germany. Together with Macopharma, both companies are part of the GMPi Group, a leading alliance in the field of blood donation and blood bank technologies.

Lmb designs and manufactures high-quality medical devices such as blood donation monitors, blood separators, tube sealers, and platelet storage systems, serving healthcare institutions and blood banks worldwide. To support our growing international Quality Management team and certification programs, we are looking for a Quality Management Engineer to join our team in Niš.

Your Role

As a Quality Management Engineer, you will play a key role in maintaining and continuously improving our Quality Management System in compliance with ISO 13485, ISO 9001, EU MDR 2017/745, FDA 21 CFR Part 820, and MDSAP. You will work closely with engineers, developers, and production teams to ensure that all processes, documentation, and products meet the highest international quality and regulatory standards.

Main Responsibilities

• Review, analyze, and evaluate test reports, production data, and nonconformities, applying engineering and manufacturing knowledge.
• Create and update test protocols, inspection checklists, and process documentation according to current technical and regulatory requirements.
• Prepare, review, and submit technical documentation for CE-marked products, coordinating approvals with management and notified bodies.
• Support preparation of registration submissions and ensure alignment with international regulations requirements.
• Develop, implement, and maintain QMS processes and documentation in line with ISO 13485, ISO 9001, MDSAP, MDR 2017/745, and FDA 21 CFR Part 820.
• Monitor and track project and product documentation to ensure timely completion and submission.
• Participate in root-cause analysis, CAPA, and continuous improvement activities to prevent recurrence of nonconformities.
• Conduct or support internal and external audits and assist in preparation for regulatory or notified-body inspections.
• Evaluate supplier quality performance, support supplier qualification, and collaborate on corrective actions when required.
• Analyze production and quality data using basic statistical tools to identify trends and improvement opportunities.
• Serve as a communication link between Development, Production, Purchasing, and Quality Management teams.
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Your Profile

• University degree in Engineering, Quality Management, or a related technical field.
• Minimum 2–3 years of professional experience in production, engineering, or quality management (mechanical, electronic, or software environment).
• Sound knowledge of ISO 9001, ISO 13485, MDSAP, MDR 2017/745, and FDA 21 CFR Part 820; experience with 510(k) submissions is an advantage.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook) and AI tools.
• Analytical, structured, and independent working style with strong problem-solving abilities.
• Reliable, proactive, and eager to learn and grow.
• Excellent communication and teamwork skills.
• Fluent English (written and spoken). German or French is a plus.

What We Offer

• A key position within an international medical device group (GMPi) recognized for quality and innovation.
• Collaboration with German and international colleagues across Lmb and Macopharma.
• Opportunity to work on innovative, life-saving medical devices used in blood donation and transfusion medicine worldwide.
• Long-term career growth and continuous training within an ISO 13485 and MDR 2017/745 certified organization.
• A professional and supportive working atmosphere at our modern facility in Niš.