QARA Specialist

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

QAELUM NV is a fast growing medical software solutions provider caring about patient safety and quality improvement in medical imaging environments. Started as a startup of the University Hospitals of Leuven, Belgium, it is now the preferred choice for major institutions all over the world. 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 strengthen our team we are currently looking for a QARA Specialist.

Your responsibilities and tasks

Your responsibilities will consist of:

  • Maintaining and continuously improving the quality management system in line with the business needs and compliant with the required standards and regulations for that region and/or division

  • Acting as owner for monitoring of Quality policies, procedures and instructions

  • Managing documentation control system and review documentation

  • Proposing, supporting and leading documentation control improvement initiatives (short/mid-term) and best practices

  • Collaborating with process owner to maintain documented information up-to-date and identifying risks and opportunities

  • Providing inputs to proper documentation management in line with ISO standards, regulations and business needs

  • Facilitating improvements and corrective actions (CAPA) with main focus on process improvements

  • Ensuring the promotion of awareness of applicable regulatory and QMS requirements throughout the organization

  • Organizing internal trainings on quality related procedures and instructions or general quality trainings

  • Supporting the organization to plan, coordinating and conducting external certification and required corrective actions to monitor the progress

  • Managing external certification audits for ISO13485 and ISO27001. Managing contract, invoices and communication with certification body

  • Providing monitoring, measuring and reporting internal audit findings performance figures, deviations, progress, and internal auditing performance or the need for improvement and changes in line with the divisional quality plan and objectives (e.g. inputs from certification audits, customer audits, regulatory requirements, organizational changes, etc…)

  • Identifying training needs and organize training to meet quality and regulatory standards and maintain internal auditors training records

  • Setting up and maintaining all regulatory files

  • Following up on registration process in international regions

  • Management of Technical file

Our wishlist

We expect you to hold a bachelor’s degree in Science or any other relevant degree with at least 3 years of experience in QA\QMS management.

Experience with most of the following technologies is a must:

  • In depth understanding of QMS requirements to achieve ISO13485

  • Experience in Regulatory Affairs and good understanding of EU MDR

  • Experience in coordination of external audits (certification bodies, Competent Authorities or customers)

  • Experience in internal auditing against QMS

  • Excellent verbal and written communication skills, listening skills and able to cope with stressful situations

  • Good understanding of Quality organizational knowledge

  • Sound judgment and high level of integrity and ethics

  • Analytical, investigative and decision-making skills

  • The ability to deal with and manage a diverse and demanding workload

  • Influencing skills and experience in coordinating change management or improvement projects

  • Good understanding of medical device specific process requirements and basic understanding of the medical device regulations in the different countries

  • Knowledge of medical device software is a plus

  • Knowledge of ISO27001 is a plus

You communicate fluently in English (other languages are a great asset) and love to learn and improve. What it does for us, is your drive for design and development responsibilities and your intrinsic will to take initiative.

How we support you

We provide an internationally oriented working atmosphere in which a team of professionals are dedicated to improve quality in medical imaging environments. Together we build on the next quality improvements in healthcare. You will enjoy the freedom and responsibilities that a young fast-growing company as 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 and every opportunity to take part in additional training courses in-house or elsewhere. Your workplace will be in Leuven but your contacts will be global. Next to this you can count on a comprehensive and market conform remuneration package. 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 This email address is being protected from spambots. You need JavaScript enabled to view it..

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