Qa Engineer Software Development

WHAT ARE YOUR RESPONSIBILITIES?

  • You will provide input from a quality and compliance perspective to software development and validation teams
  • You will support the creation of the software development, verification and validation documents and to review them for adherence to relevant QMS processes
  • You will support the roll-out of the software products from a Quality perspective, as defined per project plans 
  • You will follow-up Quality events (deviations, design changes) related to software products, more specifically to support event owners and/or stakeholders with regard to investigation, root cause analysis and definition/implementation of action plans related to software products; to verify on completeness of the investigation and to motivate impact assessments and disposition decision, if applicable

WHO ARE WE LOOKING FOR?

  • You have a master’s degree in life sciences or a PhD (e.g. Biomedical Engineering, industrial pharmacist, bio-engineer, engineering…) 
  • You have experience in a pharmaceutical/GMP environment 
  • You have Knowledge of  ISO 13485, 21 CFR part 820 and ISO14971, ISO62366 as well as knowledge on technical standards, e.g. ISO62304 and GAMP, is an asset
  • You have good communication skills and you are a team player
  • You have good writing skills in Dutch or French and English

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 Antwerp Young Entrepreneur of 2019!
  • A flat organization in the broadest sense of the word
  • An increase in your IQ through our extensive training package
  • A hip office with air hockey table
  • More muscle mass through our weekly boot camps
  • 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.