Medical Device Engineer

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?

  • Working in close collaboration with production, QA, engineering, QC, process/validation engineers, supply chain …
  • Handling deviations during lab testing and production runs and check for improvements
  • Development of a Standard operating Procedure (SOP), related Work Instructions (WI), forms, checklists, protocols, reports
  • Tracking and reporting on project deliverables
  • Preparing all documentation for filing to authorities
  • Follow regulations on medical devices
  • Implementation/maintenance of Quality Management Systems according to ISO13485

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) 
  • Good project management skills
  • You have excellent Dutch and English verbal & written communication skills.

WHAT DOES QBD OFFER YOU?

  • A young, dynamic company with a let’s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
  • Personal and professional development through guidance, education and knowledge sharing
  • A competence development model focused on your personal ambitions
  • An attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.

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