Vacancy Design Assurance Engineer – Heerenveen
For an organisation that develops, produces and sells innovative equipment and application software for hospitals for the nuclear medicine and (radio) pharmaceutical industry, we are looking for a Design Assurance Engineer to strengthen the quality team. This organisation is a world-leader in their business and provide custom made solutions for hospitals and big names in the industry. The quality team that you will be a part of is small which results in a large amount of responsibility and ownership in your tasks and projects.
Within this role you will be responsible for the input into several teams such as quality, production and R&D to ensures the design of the products. Your tasks will be related to building and maintaining technical documentation. By being in touch with all relevant stakeholders you lead and participate in risk management and design review sessions. Additionally you guide and execute (process) validations and associated tests. Since you will be a part of the quality team, you support the QMS with particular focus on CAPA system, continuous improvement activities, and internal audit system.
We are looking for someone with the following skillset:
- Bachelor degree
- More than three years of experience in a similar role in a highly regulated industry
- Fluent in English, written and spoken
- Experience in product development and life cycle management (product maintenance), preferably with software development and/or hardware/systems development
- Strong communication skills throughout all levels of the organisation
- Pre: Experience in 21CFR820 and ISO13485 quality systems regulations
- High level of responsibility in the quality team
- Training in Medical Devices regulations
- Salary range of 40.000 – 65.000
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Consultant | Medical Devices