Medtronic
Maastricht, Netherlands
Our offer
We offer you a position in which you perform Quality Assurance activities for the core processes; design & development, manufacturing and translations to ensure compliance with the BRC Quality Management System, MDD/AIMDD, ISO13485, ISO14971 and other applicable requirements.
In this position you will focus on participating in the cross-functional design and development project teams providing Quality Assurance support to ensure the BRC custom-made, clinical and commercial devices are designed and manufactured in compliance with the BRC Quality Management System.
Furthermore you will maintain a compliant and effective BRC Quality Management System by means of driving continuous improvement activities, providing training, performing audits, monitoring KPI’s, initiating CAPAs, performing supplier evaluations, etc.
Your profile
- Bachelor of Science degree in Engineering (or equivalent);
- Knowledge of ISO13485 and preferably ISO14971;
- Min. 3 years of relevant working experience in a high tech environment, preferably medical device or pharmaceutical industry;
- Furthermore you have experience with verification, validation, and qualification activities, as well as regulatory requirements such as risk management in the area of design & development and manufacturing;
- You are a customer focused team player. Besides the ability to manage multiple tasks you dispose of good problem-solving skills and a high attention to detail and accuracy. You are result-oriented and used to take initiative and you demonstrate the ability to work effectively and pro-active on cross-functional teams. You are a good communicator and fluent in English, both in writing and speaking.