In this role, you’ll be responsible for all quality management-related activities and ensure they are carried out in a manner that is compliant with the applicable regulatory requirements.
- Manage quality in the product development lifecycle (Review processes, Design verification & validation and Change control)
- Risk management
- Quality events management (Non-conformances, Customer complaints, CAPA activities)
- Documentation management
- Quality policies, procedures and instructions (Medical device file)
- Training management
- Working closely with other developers, UX designers, business, and systems analysts
- A minimum of a Bachelor’s degree in a relevant area
- At least 3 years’ experience in QA/RA Medical Devices. Experience with software is a plus
- Familiar with ISO13485 and MDR
- Excellent English verbal and written skills
- Good communication, analytical skills, ambitious and motivated attitude
ORGANISATION AND OFFER
This organisation is creating a process-oriented software platform for dialysis centers to support, among others, nurses.
To the right candidate, they will offer the ability to develop in a fast-paced international and rapidly growing R&D team, working with exciting projects and product development. In addition to a competitive salary and benefits package, you will land in a friendly and dynamic workplace environment where people enjoy autonomy and taking initiative.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org