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, Quality Assurance, …
- 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), regulatory standards for Medical Devices (21CFR820 & EU MDD/MDR) or software used for Medical Devices (IEC 62304) is a big plus
- 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.