We are looking for a

Quality Engineer

ABOUT AMNOVIS
Amnovis is an additive manufacturing production and engineering start-up that’s built on no nonsense entrepreneurship. At Amnovis, we believe the full potential of additive manufacturing can be unlocked through thoughtful innovations, which we enable for the utilization in regulated and high-tech industries. We strive to be the catalyst of the innovation process, continuously looking for technical challenges and opportunities to redefine the state of the art in AM. Currently, the Amnovis team consists out of 7 people. 

JOB DESCRIPTION
As quality engineer you are the foundation on which Amnovis builds its confidence in every part. You maintain our ISO13485:2016 certified quality management system and are continuously looking for ways to improve the robustness and reliability of our operations. You are the main point of contact for the day-to-day quality assurance, to customers, suppliers, and colleagues. Additionally, you play a key role in the risk management, validation, and control activities of Amnovis’ production processes and customer products. Put simply, you are the core of Amnovis’ commitment to quality, and convey this mindset to everyone around you.

YOUR TASKS
Minimizing CAPAs, complaints and non-conformities, but managing them when necessary
Defining and implementing improvements to Amnovis’ quality management system
Performing risk analyses, and managing the implementation of the defined controls
Hosting audits for customers and certification bodies 
Establishing and executing optimized process validation strategies
Writing SOPs, work instructions, specifications, …

YOUR RESPONSIBILITIES
Manage the quality management system and the risk management process
Maintain Amnovis’ ISO 13485:2016 certification
Stay up to date on the latest regulatory requirements applicable to Amnovis
Support our Engineering teams in defining and managing product and process controls
Manage overall customer satisfaction and minimize operational cost of non-quality

YOUR PROFILE
You have a MSc in engineering or science, with 2 - 3 years of relevant experience. Specializations in life sciences, biomedical engineering, or manufacturing techniques are considered a plus.
You have a working knowledge of ISO 13485:2016
You understand the principles of risk analysis and process validation
You have demonstrated excellent documentation practices, attention to detail, and punctuality
Professional proficiency in English, both written and spoken. Dutch is a plus.
You are comfortable working independently with minimal guidance
You have basic project management skills
You have a no-nonsense entrepreneurial mindset

OUR OFFER
A challenging job in a lean and mean startup company, with significant career development opportunities
Nice colleagues, a great boss 😉, but even better customers 😊
Attractive salary packages including extralegal benefits
Sorry, no ping-pong or pool tables at Amnovis (yet) ☹️
Working location with excellent connectivity to public transportation
CONTACT US
No doubt you want to apply for this awesome job. Please send your CV and cover leter to  jobs@amnovis.com. If you are not sure (really?) or if you want to have more information, please send your question(s) to  jobs@amnovis.com or call us at +32 16 14 60 76.