Netherlands, Gelderland, Nijmegen€3,400 - €4,600 per monthQA/RA
We are looking for a structured and pragmatic professional to expand our QA/RA team. Our team focuses on improving the quality management system and the registration of ScreenPoint’s products around the world. With a rapidly growing number of customers we are looking for an enthusiastic and skilled QA/RA Officer.
You will work in the QA/RA department with many interactions with the research, software development, clinical, sales and operations teams. You will support with the implementation and improvement of the quality management system. In addition, you will help the regulatory research and registration of our products all over the world.
Duties and responsibilities
- Preparing the management review, internal audits and data analysis of the QMS.
- Creating and reviewing technical documentation of ScreenPoint’s products (e.g. STED, risk assessment, software documentation).
- Support with handling nonconformities, complaints, and CAPA’s.
- Research of local jurisdictions around the world and handling product registrations.
- Perform impact assessments of newly published regulations, standards and guidances.
- Provide hands-on support to the other departments related to QA/RA topics.
- BSc or MSc degree, preferably with a technical or scientific education in Business Administration, Biomedical Technology, or similar.
- Minimum of 2 years experience in a QA/RA position for Medical Devices.
- Experience with ISO 13485.
- Pragmatic and pro-active attitude.
- Strong organizational, analysis and communication skills.
- Fluent in English.
- Experience in a QA/RA position for medical devices.
- Knowledge of medical device regulations (e.g MDR, FDA) and standards (ISO 14971).
- Knowledge of medical software development (e.g. IEC 62304).
How to apply
it-8 is responsible for this vacancy. Please send your application to Sandy Lufino Bastmeijer (firstname.lastname@example.org), or call/app Sandy for more information (+316 2150 9112).