We are seeking a highly skilled Sterilization Specialist to join our R&D team at LiNA Medical ApS. As a key member of our team, you will be responsible for ensuring the sterilization aspects of new medical devices meet the highest standards of performance, safety, and cost-effectiveness.

• Determining the most suitable sterilization method for products, taking into account performance, safety, and cost factors.
• Developing, planning, executing, and documenting sterilization qualifications and validations.
• Collaborating with external suppliers and in-house microbiological laboratory to conduct sterilization studies and microbiological tests (bioburden, sterility, endotoxins).
• Preparing technical and quality documentation required to meet regulatory requirements in the sterilization area.
• Supporting project teams in product design and materials selection in terms of suitability for sterilization.
• Transferring knowledge and project outcomes to operations teams.
• Working in line with Quality Management System procedures and international standards and regulations relevant to Medical Devices (ISO 13485, MDR 2017/745, ISO 11135, ISO 11137).
• Raising awareness of R&D teams on sterilization aspects.
• Cooperating with project teams, production teams, QA and RA departments, technical consultants, and suppliers.
• Reporting to line managers and project managers.

• Creating Quality Management System documentation related to sterilization in the development process.
• Participating in supplier qualifications, supplier audits, and supplier claim processes related to product sterility.
• Involvement in problem-solving activities, root cause analysis, NC & CAPA processes.

• Minimum 3 years of experience in Microbiology or Quality, preferably in the Medical Device Industry.
• Knowledge of relevant industry standards (like ISO 13485, ISO 14971, ISO 11135, ISO 11137, ISO 10993) is an advantage.
• Knowledge and ability to apply quality tools and methods.
• Experience with metrological and laboratory equipment. Willingness to work hands-on with devices.
• Ability to work in a team and prioritize workload.
• Willingness to travel less than 5% of the time.

• Working in the R&D department in an international, interdisciplinary team.
• A 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).