Sterilization Specialist (R&D) – Praca na etat, Poznań Sady

Responsibilities :

Participation in R&D projects, being responsible for sterilization aspects of new medical devices, especially with following duties:

• Determining best sterilization type for products, in view of performance, safety and cost aspects, including but not limiting to ethylene oxide, gamma or E-beam sterilization
• Develop, plan, execute and document sterilization qualifications / validations
• Organizing sterilization studies and microbiological tests (bioburden, sterility, endotoxins) together with external suppliers and in-house microbiological laboratory
• Preparation of technical and quality documentation required to meet regulatory requirements in sterilization area
• Supporting project team in product designing and materials selection in regard to suitability for sterilization
• Transfer of knowledge and project outcomes to operations team
• Work in line with Quality Management System procedures and international standards and regulations, relevant for Medical Devices (like ISO 13485, MDR 2017/745, ISO 11135, ISO 11137)
• Raising awareness of R&D team in regard to sterilization aspects
• Cooperation with project teams, production team, QA and RA departments, technical consultants and suppliers
• Reporting to line manager and project manager

Beside of projects:

•  Creation of Quality Management System documentation related with sterilization in development process
• Participation in supplier qualifications, supplier audits and supplier claim process related with product sterility
• Involvement in problem solving activities, root cause analysis, NC & CAPA processes

Requirements :

• Minimum 3-years (>5-years is preferred) of experience in Microbiology or Quality, ideally in Medical Device Industry
• Master’s degree in engineering (preferable: Biology, Biotechnology, Biomedical Engineering, Engineering Management)
• Knowledge of relevant industry standards (like ISO 13485, ISO 14971, ISO 11135, ISO 11137, 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
• Willing to travel less than 5% of time

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)).