Design Control Specialist R&D

6 dni temu


Poznań, wielkopolskie, Polska Lina Medical Polska Pełny etat

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.


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