- 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 R&D
- You will report to the Medical Quality Manager and are part of the Quality department in the Medical Business Unit.
- This department is responsible for the Quality Assurance during the entire life cycle of our medical devices, in a quality system that meets the requirements of ISO 13485 and global regulatory requirements such as FDA QSR.
- In this function, you will be responsible for Quality Assurance of our medical devices and medical device software during development Phase and for development related aspects during post-market surveillance.
- Together with Development management in the Medical Business Unit, you drive continuous improvement and are accountable for the compliance of the medical device Development processes, this to ensure innovative, safe and effective products can be made available to patients.
- In this exercise, you assist with writing, reviewing and approving standard operating procedures/work instructions and forms to ensure regulatory compliance.
- You manage CAPA projects to ensure appropriate corrective and preventive actions are implemented to correct design issues and improve the development process
- You demonstrate compliance of the development processes during audits and inspections by our Notified Body, customers and Regulatory Authorities
- You are responsible for the quality assurance during development projects, including:
- Design review: Participate in and approve the outcome of regular multi-discipline review of the design in development
- Design History File review: Confirm the design documentation is compliant with applicable regulations
- Design Risk management: Participate in and approve the outcome of design risk analysis
- You ensure your internal clients in the Development department are performing according to the GMP and the standards in our Quality Management System by:
- Helping Development management to identify competence and training gaps
- Organizing and leading audit and inspection readiness initiatives, including training and mock-up audits
- You are passionate about quality and continuous improvement and strongly care about patient safety and the satisfaction of our end customer, the surgeon
- You are familiar with Risk Management methodologies and Good Documentation Practices
- Knowledge in or past experience working with ISO 13485 quality system standard, FDA QSR and European MDD/MDR is a plus
- You are proficient in English, 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 minded and take action when you notice issues or opportunities for improvement
- 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.