Validation Specialist of Disinfection and Sterilizations Methods for Medical Device
Do you have experience with the validation of disinfection and Sterilizations methods for medical devices? And do you work well within defined sets of regulations, quality standards and can deliver with respect to timelines? Would you like to advise doctors in hospitals and clinics worldwide?
We are looking for a Validation Specialist to strengthen our capabilities within disinfection and sterilization. You will join a dynamic, international and innovative environment, where highly skilled professionals work closely together to develop next generation of medical devices to improve clinical results and enhance patient outcomes.
As a Validation Specialist, you will be part of a team that has global collaboration with manufacturing in the USA, cooperation with external laboratories and partners worldwide. The team is responsible for introducing and sustaining approved disinfection and sterilization methods across our product portfolio. We work with R&D, QA, RA, service, sales and marketing to support our customers with the latest guidance for all our products. The requirements for new disinfection and sterilization methods for medical equipment are growing rapidly and at the same time regulatory requirements in the field are increasing worldwide. Therefore, we are looking forward to
You will participate in development project from the beginning with planning, coordination of analyzes, tests, implementation and application of methods for medical ultrasound products. You will also support continued testing and research to support existing products. Additionally, you must stay up to date with customer needs, trends and relevant legislation worldwide, to ensure that BK Medical follows developments in the area and make safe compatible products for the wide range of our customers.
- Your educational background may be varied, as the job includes evaluation of chemical compatibility of materials, microbiological assays of efficacy, and knowledge of material science. We imagine that you hold a masters degree in Pharmacy, Chemical Engineering or have other relevant experience
- You have experience with chemical disinfection and sterilization of medical devices, or with products / methods used for general reprocessing of medical devices
- You have experience of working in regulated areas, such as in medical device or in the pharmaceutical industry
- Preferably experience with project management of smaller projects
- You are fluent in English, both in writing and speaking
- You have a collaborative mind-set and use your great interpersonal skills to communicate openly
- You are a good coordinator who can deliver
- Thrives in an environment with new developments and new challenges
- Committed, structured and solution-oriented
- You thrive on being systematic, thorough and detail-oriented while being able to see the bigger picture
- Ability to influence and respond to stakeholders across the organization and facilitate meetings and workshops in order to reach decisions and ensure progress
You will become part of a culture where there is room to be creative and where there are openings to new ideas, thoughts and better ways of doing things. You will therefore find that you have the opportunity to influence solutions and work tasks. We are in the process of developing a new department, which will expand competencies within reprocessing, biocompatibility, material science and material compliance. This department will be part of product development, where we can contribute to the development of various medical ultrasound products and support sustaining operations.
The Department of Materials Science is located in our European head office in Herlev, where the main R&D organization are. We offer you also a number of social activities that are run by colleagues and where the culture is characterized by a relaxed tone and great trust in the individual.
You are of course also very welcome to contact Jens Weirsøe, Vice President Quality & Regulatory on +45 4452 8146 or send an e-mail to firstname.lastname@example.org.
We hold ongoing conversations
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