Quality Assurance & Quality Control Specialist (Medical Devices)

Job Description:The ideal candidate will support activities related to quality assurance and quality control throughout the manufacturing, testing, and distribution processes of medical devices. The main goal of this role is to maintain a high level of product compliance with applicable standards (including ISO 13485, MDR 2017/745, FDA 21 CFR Part 820) as well as with the internal quality procedures of the company.Responsibilities:• Participating in the development, implementation, and maintenance of the Quality Management System in accordance with ISO 13485, EU regulatory requirements, and FDA regulations.• Performing quality inspections of components, subassemblies, and finished products.• Preparing and maintaining quality documentation and control reports (e.g., measurement records, nonconformity reports, complaint reports).• Supporting root cause analysis of nonconformities and implementing corrective and preventive actions (CAPA).• Collaborating with Production, R&D, and Procurement teams regarding supplier and material quality.• Supporting internal and external audits (e.g., notified body audits).• Supervising the calibration and verification of measuring instruments.• Reviewing technical and production documentation to ensure compliance with regulatory requirements.Requirements:• Higher technical education (preferred fields: biomedical engineering, biotechnology, chemistry, mechanics, materials science, or related).• Basic knowledge of ISO 13485, ISO 14971 (risk management), MDR 2017/745, and FDA 21 CFR Part 820.• Ability to work with technical and quality documentation.• Accuracy, reliability, and good organizational skills.• Experience in the medical or manufacturing industry is an asset.• Proficiency in English.• Creative problem-solving skills.• Proactive approach to work.We Offer:• Opportunities for professional development in the medical device industry with high quality standards.• Training in quality management systems (ISO 13485, MDR, FDA 21 CFR Part 820).• Collaboration with an experienced team of specialists.