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. 

What do we expect from you as a Medical Device Specialist?

• 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
• We count on you for the development of a Standard operating Procedure (SOP), related Work Instructions (WI), forms, checklists, protocols, reports
• 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
• A true QbD’er can be recognised by the following qualities:
  • Resilient: Your strong and positive attitude helps you overcome any challenge
  • Hungry for knowledge: You are always open to learning
  • No BS mentality: you can be straightforward in a respectful way
  • Innovative: You are constantly looking for new and better solutions
  • (Not too) serious: your job is serious, but you don’t take yourself too serious.

What’s in it for you? 

• QbD offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed. 
• As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
• Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together 
• Our promise to you: 
  • As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
  • Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
  • In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done! 

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!