Itémedical is a fast growing Dutch medical software company, founded in 2000 with offices in The Netherlands, Belgium and the UK. We are on a mission to create a healthier environment in critical care for both patients and medical teams. We are now searching for an enthusiastic Quality Assurance Officer Medical to strengthen our team.
Our innovative solutions address challenges such as reducing the number of medical alarms and alarm fatigue in critical care. To achieve this, we smartly combine alarms and other information from diverse medical devices to provide smarter and more efficient patient monitoring. Our software applications focus on intensive care units (ICU) and other hospital departments with monitored patients. Our applications deliver information for medical purposes, management, as well as scientific research.
As a Quality Assurance Officer Medical, you will play a vital role in contributing to our Regulatory Affairs and to continuously improve our Quality Management System and our medical software solutions.
- The regulatory aspects mainly concern the EU Medical Device Regulation (MDR), standards such as ISO 13485, and guidance such as provided by the Medical Device Coordination Group (MDCG)
- You will assure that all applicable requirements are covered by the quality system and the medical device products
- You will take part in audits, either as an auditee or as an internal auditor
- You may specialize in test automation, performance tests, usability tests, and/or security
In this position you will become part of both the Quality Team and the R&D Team. The Quality Team will consist of six specialists from different disciplines. The R&D team consists of ten specialists in development, testing, and quality.
- University education: PhD, Master, or equivalent
- Experience with quality, regulations and/or (ISO/IEC) standards
- Strong communicative skills, verbal and written
- Process-minded and affinity with testing complex systems
- Able to work independently as well as in a team
- Verification of risk reduction measures
- Fluent in English, Dutch is a plus
- Knowledge of TMAP or ISTQB is considered an advantage
- Knowledge of SQL and test automation (preferably Selenium, C#) is a plus
- A market-conform salary and pension plan
- A permanent contract for a perfect match
- Flexible work arrangements, including the option to work partially from home
- The opportunity to further develop yourself, both through internal coaching and internal/external training opportunities
At Itémedical we foster a customer-focused and quality-driven culture. We speak the languages of both technology and care. Join us in making a difference in the quality of care delivered on a daily basis.
Are you going to strengthen our team as our new Quality Assurance Officer Medical?