Design Control Specialist (R&D)– Praca Poznań Sady, Tarnowo Podgórne
Miejsce pracy: Wielkopolskie / Poznań, Sady – gmina Tarnowo Podgórne
LiNA Medical Polska Sp. z o.o. – producent urządzeń medycznych w obszarze ginekologii małoinwazyjnej poszukuje pracownika na stanowisko: Design Control Specialist (R&D)
Status Oferty Pracy: Aktualna
Dział: R&D
Rodzaj pracy: Pełen 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
Be part of a forward-thinking company that values innovation and excellence.
Lead a dedicated team of professionals in a supportive and collaborative environment.
Contribute to the development of life-changing medical devices.
Enjoy opportunities for professional growth and development.
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 for English language classes, fruit and snacks)
