Design Control Specialist (R&D)

Your responsibilities

• Participation in R&D projects for new medical devices development and maintenance of released products with following duties:
• Responsibility of QA aspects in development phase of new projects and sustaining already manufactured products from quality perspective
• Leading role in activities like risk management, usability, design verification & validation
• Involved in problem solving activities, root cause analysis, NC & CAPA processes
• Work in line with Quality Management System procedures and international standards and regulations, relevant for Medical Devices (like ISO 13485, FDA 21 CFR 820.30, MDR 2017/745, ISO 14971)
• Analyzing state of the art for similar products and defining input requirements for projects, in line with relevant safety product standards
• Participation in designing and executing pre-clinical tests
• Preparation of quality and technical documentation related to design development, testing, and regulatory purposes
• Cooperation with project teams, clinical experts, regulatory officers, technical consultants and suppliers

Reporting to line manager and project manager

Our requirements

• Minimum 5-years’ experience in medical device design control, regulatory affairs, or quality engineering.
• Strong understanding of design processes, regulatory requirements, and quality management systems.
• Proficiency in risk management methodologies and tools.
• Excellent communication, organization, and project management skills.
• Ability to work effectively in a cross-functional team environment and manage multiple priorities.
• Detail-oriented with a commitment to accuracy and compliance.

English: speaking / reading / writing ≥ B2

What we offer

• Full-time job contract;
• Opportunity to work in an international environment;
• A number of benefits (private medical care, sports card, flexible working time, Home Office, co-financing of holidays, co-financing for English language classes, fruit and snacks);
• Great atmosphere in the office and interesting challenges;
• Opportunity to grow with the organization and build a successful career path;

Internal and external training.