Quality Specialist
We are currently looking for a Quality Specialist for our HQ in Belgium.
Qaelum NV is one of the worldwide market leaders in dose management software. As a fast-growing medical software solutions provider, we are caring about patient safety and quality improvement in medical imaging departments. Started as a start-up of the University Hospitals of Leuven, Belgium, Qaelum is now the preferred choice for many major institutions all over the globe. We believe it is our mission to help all stakeholders, no matter what level they are at, in creating patient safe and optimized healthcare environments.
To support our growth and to strengthen our team we are currently looking for a Quality Specialist.
Your responsibilities and tasks
You support Qaelum in the implementation and maintenance of our quality management systems and procedures and in ensuring compliance with regulatory requirements.
- You assist us in further developing and implementing quality management systems and processes in compliance with ISO13485 / ISO27001
- You maintain our quality management system according to the ISO13485 / ISO27001 requirements and our internal procedures
- You prepare and review documentation, including product documentation, procedures, work instructions and other quality related documents
- You participate in risk management activities and assist in developing risk management plans
- You assist in internal and external audits and inspections
- You provide support in handling quality-related customer requests and observed non-conformities
- You provide support in country-specific regulatory and quality pathways
Your profile
The passion to ensure the safety of our patients by implementing well-controlled and maintained quality management systems and the willingness to learn and grow in the field of medical device quality/regulatory affairs are key criterions.
- You have a strong attention to detail and organizational skills, you are able to work in a small team and collaborate with cross-functional departments
- You preferably have a first good working experience in a medical device environment
- We expect you to hold a relevant Master’s or Bachelor’s degree
- You communicate fluently in English, the knowledge of other languages is a great asset
- Knowledge of ISO13485 and/or ISO27001 is a plus
- Knowledge of medical device software is a plus
How we support you
We provide an internationally oriented working atmosphere in which a team of professionals is dedicated to improving quality in medical imaging environments. Together we build on the next generation of quality improvements in healthcare. You will enjoy the freedom and responsibilities that a young fast-growing company like ours can bring to the table. As we also attach great importance to a sound work-life balance and life-long learning, we provide flexible working hours, a home-office working balance, and every opportunity to take part in additional training courses in-house or elsewhere. Your main working place will be in our offices in Leuven, Belgium (incl. flexible home-officing) but your contacts are worldwide. Next to this you can count on a comprehensive and market conform remuneration package including extra-legal benefits. We offer a full-time permanent position.
Want to apply for this job?
Qaelum looks for quality and personality, if you have an interesting skillset, do not hesitate to send us your resume. We hire people based on skills and merit no matter your age, location in the world or background. If you have interest in this vacancy, please send your CV and motivation letter to
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