Quality Engineer Medical Production Manufacturing - Belgium
- The Company Founded in 1990, It is a high-tech international company with over 1,300 employees worldwide.
- Our mission is to contribute towards a better and healthier world through its innovations in 3D printing software and in-depth knowledge of Additive Manufacturing (also known as 3D Printing).
- Our customers are part of industries as diverse as automotive, aerospace, design, healthcare and academia.
- As a growing company, our company is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology, surrounded by people passionate about their work.
Quality Engineer Medical Production Manufacturing
- You are part of the Quality Team in the Medical Business Unit and will report directly to the Medical Quality Manager
- You interface daily with operational teams. Key stakeholders are the Medical Production Team and the Process Engineering Team
- You are responsible for the quality assurance activities taking place at our medical production facility at company HQ. This means:
- You advise and support the Process Engineering Team in change management projects by making sure that quality system, regulatory requirements and manufacturing best practices are respected. This comprises active involvement from scoping till release phase
- In these process changes, you are responsible to review and approve changes to manufacturing procedures, risk management and validation activities
- You drive improvements and corrective actions by managing CAPAs. This includes performing Root Cause Analysis of quality problems, defining action plans and following up on actions till effectiveness has been verified.
- You interface directly with stakeholders in our other medical production offices in USA and Japan to align on good manufacturing practices
- You follow-up on daily quality assurance activities in medical production such as reviewing non-conforming product reports
- You have a bachelor or Master Degree in Engineering, Quality, Technical education or equivalent
- You are passionate about quality and continuous improvement, strongly care about patient safety and satisfaction of our end customer, the surgeon
- You have a high interest in additive manufacturing activities in a medical environment
- You have good communication skills and can interact with internal stakeholders to explain and position a strong quality mindset.
- You can build strong relationships with these internal stakeholders.
- You are proactive and dare to take action when you notice issues or opportunities for improvement
- You can work in a dynamic work environment
- You are a (constructive) team player striving for sustainable solutions/implementations with relationship to change management activities
- Knowledge in FDA quality system requirement and/or quality system standards will be part of the training program. If already acquired, it is a plus.
- We offer an inspiring and challenging job with growth potential in an innovative market.
- You will be part of a dedicated development team within a dynamic company that highly values openness, trust and team spirit.