VACATURE: Medical Device Specialist

As a QbD medical devices engineer you will be working on several projects within ISO13485 environments or you will help companies achieve their ISO13485 certificate. You are a communicative versatile person, capable of solving problems, investigating root causes and implementing changes.

WHAT ARE YOUR RESPONSIBILITIES?

  • You are capable of conducting internal audits regarding ISO13485, Quality management systems, QA, …
  • You will be responsible for the implementation/maintenance of Quality Management Systems according to ISO13485
  • You have an eagle eye for optimizations within quality and quality systems and are able to implement them
  • In this role you work in close collaboration with production, QA, engineering, QC, process/validation engineers, supply chain, …
  • We count on you for the development of a Standard operating Procedure (SOP), related Work Instructions (WI), forms, checklists, protocols, reports
  • As a project consultant you are responsible for the tracking and reporting on project deliverables
  • You are able to coach a small team but also to work independently 
  • You are responsible for preparing all documentation for filing to authorities
  • We expect you to follow regulations on medical devices and share your insights/knowledge within the QbD team and at our customers
  • You support in setting up the timelines for the go-to market strategy in light of the applicable regulations and the customer’s business plan

WHO ARE WE LOOKING FOR?

  • Scientific master’s degree: engineer (bio, industrial, civil), industrial pharmacist, …
  • Experience in the life science industry and in GMP, preferably in medical device projects
  • Knowledge on quality system standards (ISO 13485) or regulatory standards for Medical Devices (21CFR820 & EU MDD/MDR)
  • First experience with audits is an advantage 
  • Good project management skills
  • You have excellent Dutch/French and English verbal & written communication skills
  • A fun colleague we and our customers can rely on

WHAT DOES QBD OFFER YOU?

  • A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.

But most of all…

  • Working for the Flemish Young Entrepreneur of 2019!
  • A flat organization in the broadest sense of the word
  • An increase in your IQ through our extensive training package and interesting QbD community
  • Challenging projects at a variety of the most innovative medical devices organizations in Belgium (and even abroad)
  • A company with a clear strategy and ambition (one of our two focal points is medical devices!)
  • More muscle mass through our weekly boot camps – if you dare
  • 32 vacation days that you wish were fewer (because it's great to work here ? )
  • In short… We work, we play, we deliver, we are Quality by Design!

Interested? Apply now by sending us your CV and motivation.