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 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
- 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.