Medical Device/IVD Software Specialist

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Do you have in addition to your passion for regulatory affairs, also an affinity with IT? Would you like to be a part of QbD’s Software & Services Division and specialize in Medical Device Software Validation? Then apply now and become a member of our growing QbD team!

What do we expect from you as a Medical Device Software Specialist?

  • As a Medical Device Software Specialist, you are responsible for the tracking and reporting on project deliverables. A brief overview of what your projects can include:
    • Medical Devices
    • In Vitro Diagnostics Devices
    • Medical Device Software
  • You will work with different companies in the Life Sciences industry: the pharmaceutical and medical device companies ranging from the big, established values to the newest and most innovative start-ups…
  • You offer support to QbD’s clients from A to Z:
    • Software development
    • Software maintenance
    • Software risk management
    • Software configuration management
    • Software problem resolution and software validation processes, …
  • You take care of the analysis and implementation of our own QbD quality management software (Scilife) at customers
  • You have knowledge of ISO 13485, ISO 14971, IEC62304 and IEC 82304

 

Who are we looking for?

  • You have a scientific master’s degree  in engineering (e.g.: bio, bio-informatica, industrial, civil, …)
  • You have a first experience in the life science industry and/or in software
  • You have a big affinity with IT, software and systems 
  • Accuracy and eagerness to learn are two qualities that describe you just right
  • You have technical competences and good project management skills
  • Sense of responsibility and an analytical mind-set is self-evident to you
  • A true QbD’er can be recognized by the following qualities:
    • Resilient: Your strong and positive attitude helps you overcome any challenge
    • Hungry for knowledge: You are always open to learning
    • No BS mentality: you can be straightforward in a respectful way
    • Innovative: You are constantly looking for new and better solutions
    • (Not too) serious: your job is serious, but you don’t take yourself too seriously.

What’s in it for you?  

  • QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
  • Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed. 
  • As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
  • Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together 
  • Our promise to you: 
    • As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
    • Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
    • In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done! 

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family! 

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