Junior Quality Specialist

Il y a 5 mois


Leuven, Belgique QAELUM Temps plein

We are currently looking for a junior Quality Specialist for our HQ in Belgium.

Qaelum NV is a fast-growing medical software solutions provider caring about patient safety, efficiency and quality improvements in medical imaging environments. With our solutions, we are one of the market leaders in Europe and have installations all over the globe. We believe it is our mission to help all stakeholders, no matter what level they are at, to creating patient safe and optimized healthcare environments. Have a look at our website and learn more about our solutions and company.

To support our growth and to strengthen our team we are currently looking for a **Jr 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. We expect you to hold a relevant Master’s or Bachelor’s degree.
- 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
- 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
- Experience in quality and regulatory for medical devices is a plus
- Knowledge of ISO13485 is a plus
- Knowledge of medical device software is a plus
- Knowledge of ISO27001 is a plus
- You preferably have a first good working experience in a medical device environment

You communicate fluently in **English**, both written and verbal (the knowledge of Dutch or other languages is a great asset) and love to learn and improve. What does it for us, is your drive and your intrinsic will to take initiative. 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. We encourage a diverse environment where people are motivated to learn and to grow with the company. We hire people based on their skills and merit no matter their gender, age, location or background.

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.

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