Digital Quality Systems Specialist

Job Role: Digital Quality Systems Specialist
Location: Skopje
Reporting to: Head of QA

Established in 1984, MAK-SYSTEM’s vision is to design, develop, and deliver globally best-of-breed software to manage Blood, Plasma, Tissue, and Cells from end to end using the best technologies and functionalities for the patient’s benefit. Our software solutions continuously support the digital transformation of organizations such as

• Blood Centers
• Plasma Centers
• Transfusion Services
• Tissue Banks
• Stem Cell Labs
• Cell and Gene Therapy (SME to Big Pharma, CMOs, Hospitals)

The Digital Quality Systems Specialist partners with Quality and business process owners to enhance operational excellence, by optimizing the use of digital systems and data. Is responsible for implementing and improving digital solutions that support our software lifecycle and Quality Management processes.

The Digital Quality Systems Specialist combines technical expertise with an understanding of quality principles and a commitment to continuous improvement. This role plays a pivotal role in safeguarding product integrity and patient safety while driving innovation through AI-powered solutions.
This role contributes directly to maintaining an inspection ready state, supporting audits, and ensuring that digital quality platforms operate reliably and consistently across the organization.

Key Responsibilities:

• Implement and configure digital quality solutions, including ALM and eQMS platforms, ensuring seamless integrations between systems and supporting data migration activities.
• Design, implement, and maintain workflows within digital platforms to ensure alignment with regulatory, compliance, and quality standards.
• Support core quality processes in collaboration with the Quality team, including SOP development, CAPA management, and certification activities.
• Assist in preparations for internal and external audits, providing system evidence, documentation, and process support.
• Develop dashboards and analytical reports to improve KPI tracking, operational insights, and management visibility.
• Drive continuous improvement initiatives by identifying system enhancements, automation opportunities, and process optimization measures.
• Support the adoption, implementation, and governance of AI‑enabled tools within the Quality Management System.
• Collaborate closely with Quality and IT stakeholders to ensure system capabilities meet business and regulatory requirements.
• Create comprehensive documentation and training materials, and deliver day‑to‑day operational support for relevant digital platforms.

Objectives:

• Improving QMS Effectiveness
• Ensuring compliance
• Successful audits and certifications

Previous Experience/Qualifications:

• Bachelor’s degree.
• Strong digitalization and integration skills across diverse tools and platforms.
• A structured, rigorous, and compliance-oriented mindset to ensure quality standards are met.
• Familiarity with AI tools.
• Ability to learn regulatory requirements and apply them effectively (training will be provided).
• Ability to lead cross-functional projects, act with speed, and deliver practical solutions.
• Excellent communication clarity and training skills.
• Advanced English language skills (written and spoken).