Quality Manager – Medical Devices

About Us

LMB Soft d.o.o. Niš, a research and development company with over 40 years of experience, is a trusted leader in the medical technology field. We specialize in the development and production of blood transfusion devices. We are proud to be part of the MacoPharma Group, a global leader in the manufacturing of blood bags and in-line systems.
Integration with international teams and systems enables our employees to gain professional development and valuable experience in a dynamic and multidisciplinary environment. For our facility in Niš, we are looking for an experienced Quality Manager to lead and further develop our quality team.

As Quality Manager, you will manage the QA team and be a key link between development, production and top management. You will be responsible for maintaining and developing the QMS in accordance with ISO 13485 standards, coordinating audits, managing deviations and CAPA processes, as well as reporting directly to the company director.

Responsibilities of the Quality Manager

• Ensures compliance of the quality system with ISO 13485 and other regulatory requirements, by defining quality policy, procedures and standards
• Organizes resources for QA activities and prepares annual plans
• Proposes and implements measures for continuous process improvement, monitoring relevant performance indicators (KPIs)
• Evaluates the impact of technical changes and their integration into the quality management system (QMS)
• Analyzes and measures the impact of regulatory and technological changes, proposing and implementing necessary organizational measures
• Monitors and analyzes data from incoming, final and in-process inspection and customer complaints, manages deviations (CAPA, OOS) and solves problems through root cause analysis and corrective actions
• Reviews and optimizes the change control process and coordinates quality data for post-market surveillance (PMS) purposes
• Prepares the annual plan and coordinates internal and external audits (ISO 13485), including audits by notified bodies, regulatory inspections, suppliers and customers as needed
• Represents the company as the primary point of contact with notified bodies and participates in audit activities across multiple locations
• Manages the preparation of technical files for CE marking (in-house developed and OEM products) and product registration documentation
• Prepares and manages the QA department budget
• Defines priorities in resource allocation for strategic and operational projects and promotes efficient project execution through team contribution
• Develops, strengthens and improves a collaborative, team-oriented work environment and actively contributes to strengthening organizational culture and cross-department cooperation
• Provides leadership, coordination and guidance to the team, supporting their professional development
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Qualifications and Competencies

• University degree in a technical field (mechanical, electrical, industrial or biomedical engineering, etc.), or a master's degree in a relevant field
• At least 5 years of relevant work experience in quality management, including experience managing quality policies, processes and projects in a multicultural environment
• Good knowledge of the ISO 13485 standard (knowledge of FDA regulations and MDSAP standards is an advantage)
• Good computer skills (Excel, Word, PowerPoint, Outlook)
• Strong organizational and leadership skills, with the ability to lead and develop a team
• Fluent/working knowledge of English (written and spoken)

What We Offer

• Excellent salary for your excellent performance, plus an annual bonus and private health insurance
• The opportunity to lead and shape the quality system, working directly with top management
• Involvement in international team collaboration and knowledge exchange
• Opportunities for professional growth in a stable, forward-looking industry

Become part of a team that ensures our clients' medical devices, used by people around the world, meet the highest standards of quality and safety.