Informacje o stanowisku

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, MDD 93/42/EEC, 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 (like IEC 60601-1, ISO 10993)
• 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

Requirements :

• Minimum 2-years (>5-years is preferred) of experience in Quality or Engineering, ideally in Medical Device Industry
• Master’s degree in engineering (preferable: Engineering Management, Quality Management, Biomedical Engineering)
• Knowledge of relevant industry standards (like ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11607, ISO 10993) will be advantage
• Knowledge and ability to apply quality tools and methods
• Experience with metrological and laboratory equipment. Willingness to work “hands on” with device
• Ability to work in a Team and prioritize own workload

We offer:

• Working in the R&D department in an international, interdisciplinary team
• Great atmosphere in the office and interesting challenges
• Opportunity to grow with the organization and build a successful career path
• A number of benefits (private medical care, sports card, flexible working time, English lessons)

Poznań - Oferty pracy w okolicznych lokalizacjach