Quality Engineer ( Medical )

Do you want to help build tomorrow’s world? Welcome to Comate, where we develop innovative high-tech hardware from scratch for pioneering companies across all possible industries: from the most secure cryptowallet on the market and a design snowplough to a device that makes hip surgery more efficient for surgeons and patients alike. Our robots, IoT devices and other high-tech products have already won dozens of international awards. In 2019, we were voted SME of the year.

We currently are looking for a talented and passionate Quality Engineer like you. Do you only strive for excellence and do you want to grow your career in step with our company? Then perhaps you’re the M/F/X we’re looking for.

You will work together with a multidisciplinary team of engineers and designers on the development of innovative products and machinery. The aim of our passionate team is to cooperate with our clients in order to develop a unique product that is more advanced than anything that is currently available on the market. As a Quality Engineer, you will be involved in various projects to ensure all quality aspects related to the development of innovative (non- ) medical devices and products.

What does this mean?

You will be responsible for Quality within Comate, meaning you will take care of the following

• Maintain QMS: Supports the management of the Comate Quality Management System (QMS), compliant to ISO13485, by cooperating in adaptations and further improvements to the QMS
• Assure consistent quality within projects (Quality in Projects – QP): Support the project team in correct application and execution of the Comate Quality Management System (QMS) and development process with primary focus on Healthcare projects
• Handle Non-conformity (NC) & Corrective Actions / Preventive Actions (CAPA)
• Supplier Management
• Perform / assist in internal audits and client audits
• Support in production quality control

Sounds great! Am I the Quality Engineer you are looking for? Let’s see

• You have obtained a Master in engineering
• You are fluent in English (oral and written)
• You have a proven desire for achieving excellence in customer satisfaction, process and product quality and reliability
• You keep up a high personal quality standard with a good eye for details
• You are communicative and a strong team player
• Experience in a quality role / with quality management system in a medical environment
• Thorough understanding of ISO 13485:2016
• Thorough understanding of and experience in ISO 14971:2019 and risk management

Why should you apply?

• You will be joining a team of enthusiastic and passionate colleagues
• You will be working on the design and development of truly unique products and solutions, end-to-end. Yes, you can be an inventor! There is nothing more trilling that seeing your work out there on the market
• Comate offers a broad portfolio of training and educational courses, allowing you to grow.
• Comate is a fast-growing company, so you can grow with us and grow in your area of expertise or interest
• You will be able to work in a cool office right in the heart of the vibrant city of Leuven or Ghent
• You will get an attractive salary package with a lot of extra benefits.
• And yes, Comate is an award-winning company! We want to excell in what we do, it’s no walk in the park but our hard work pays off.