Design Control Specialist R&D
1 miesiąc temu
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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