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.