As ScreenPoint Medical is rapidly growing, we are looking for an enthusiastic and skilled QA or RA Officer. You’ll be part of a highly motivated and collaborative group of experts in breast imaging, artificial intelligence, algorithm development and clinical research who work closely together in an informal atmosphere.
What are you going to do?
ScreenPoint is looking for an enthusiastic QA/RA officer. You’ll be part of a highly motivated team to ensure we bring the highest quality breast imaging, artificial intelligence products on the market. You will work in the QA/RA department with many interactions with the research, software development, clinical, sales and operations teams. As QA/RA officer you will be responsible for 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. Your responsibilities will include:
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.
What we like to see in you.
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.
Knowledge of medical device regulations (e.g MDR, FDA) and standards (ISO 14971);
Knowledge of medical software development (e.g. IEC 62304).
Why would you apply?
Help to build an innovative solution to improve health worldwide and be part of an ambitious and fast-growing team in Nijmegen;
Office located near Nijmegen-Heyendaal train station with beautiful views from the 7th floor;
Room for personal development and growth in your QA/RA role and the opportunity to help establish the future directions of the QA/RA department;
A salary between €3.400 and €5.200 gross per month, with secondary benefits (pension contribution, possibility to participate in stock option plan);
25 vacation days (based on a 40 hour workweek or pro rata);
A hybrid way of working with flexible working hours. And the possibility to work part-time (32 or 36 hours) or full-time (40 hours).
Where will you work?
ScreenPoint Medical is a leading company that develops and markets breast image analysis and cutting edge machine learning applications and services. Our product Transpara improves breast cancer survival rates by detecting cancers earlier so that treatment can be more effective and less invasive. The company is located in Nijmegen at Toernooiveld, only a few minutes by bus or train from Nijmegen Centraal Station.
The fabric of our company is created by highly motivated and collaborative people who work closely together in an informal atmosphere. We are a hybrid working company, so working partly from home is possible.
With a rapidly growing number of customers around the world, we are looking for a structured and pragmatic professional to expand the QA/RA team. This team focuses on improving the quality management system and the registration of ScreenPoint’s products around the world.
it-8 is responsible for this vacancy. Please send your application to Sandy Lufino Bastmeijer (email@example.com), or call/app Sandy for more information (+316- 21509112).
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