QA Engineer (R&D, Design Control) – Praca na etat, Poznań Sady

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
• English: speaking / reading / writing ≥ B2

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)

Please add the following clause: I consent to the processing of my personal data for the purposes of the recruitment process (in accordance with the Act of May 10, 2018 on the protection of personal data (Journal of Laws of 2018, item 1000) and in accordance with the Regulation of the European Parliament and Council (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46 / EC (GDPR)).