FLUIDDA is an innovative company that aims to improve patient care and development of medication in the respiratory domain based on medical imaging and computer simulations. Cooperation with universities and medical research centres worldwide resulted in numerous clinical trials in over 1000 patients. Since we are a fast-growing top technology company, we are looking for a QA officer to join our team in Belgium.
The Quality Assurance Officer is responsible for developing the quality strategies, policies, processes and standards within FLUIDDA in line with the required industry standards, accreditation requirements and business requirements.
- You have 1- 2 years of experience in QA and QMS
- You have knowledge of certifications in medical devices (ISO13485, CE labels, 21 CFR Part 11, …) and affinity with using software / services as a medical device
- You have a hands-on mentality, you work accurately and you fit in an innovative environment
- You are flexible and a quick learner
- You have a good knowledge of the English language
- Plus: you have experience with ICH/GCP
- Develop and sustain the Quality Management System (QMS)
- Implement all relevant procedures described in the QMS
- Managing documentation and record maintenance of the QMS (Vivaldi)
- Manage the audit program to ensure that all nonconformities raised against certified bodies during audits are effectively corrected and independently verified
- Embed a culture of continuous improvement throughout FLUIDDA
- Lead FLUIDDA to achieve quality management system targets for customers and business goals
You may expect a job with growth potential in a high-tech biomedical company with highly motivated colleagues. The technology is innovative, making it a challenging task to continuously improve the quality. We offer a competitive salary and supplementary benefits in accordance with your level of education, age and experience.
For further questions, you can contact Nicky Verschoren at email@example.com