Global Manager Quality, Risk & Accreditations Management Medical (m/f/d) Europe-wide
In this position you will collaborate with the Notified bodies in UK,Netherlands and Germany.
- You enhance and improve the procedures together with the process owners
- You coordinate and/or perform the internal medical audits for all DEKRA divisions and arrange training tests for effectiveness
- Futhermore you participate in the Notified Body steering committee and strengthen harmonization of QMS of all DEKRA Notified Bodies
- You also monitor key performance indicators (KPIs) for the SD and Notified Bodies
- You support the set up, role out and improvement of project and data management system Task4Med (Certification knowledge database)
- Based on gap analyses of updated regulations you evaluate with process owners the potential consequences for the medical device teams
- You share process excellence an ddevelop and conduct training
- You s upport the Global market access team for global medical regulations, so that manufacturers can obtain certification or auditing for medical devices in multiple countries
- Even there is a focus on MEDICAL you will work as part of a team on the full scope of responsibilities to achieve the departmental standards.
- Masters degree in Engineering, Science, or healthcare-related field or comparable qualification
- Several years of experience in a relevant Life Science field in QA position (Medical)
- Preferably, Notified Body QA Medical experience
- Good communication and organizational skills with an eye for detail
- Desirable to possess knowledge of QA systems ISO 13485, MDSAP, EU regulations, and ISO standards 17065, 17025, and 17021
- Desirable to product standard knowledge for IEC/EN 60601 series standards
- Ability to take part in conversations and speak up about challenges, conflicts and mistakes
- Proactive, responsive, and inquisitive - constantly looking for ways to improve
- Business fluent written and spoken English, French and German language skills will be a plus
- Willingness for international travelling
Safety meets knowledge and passion - that is why you can also rely on usas an employer and we provide safety in your life. In addition to anattractive salary, comprehensive social benefits and a company passion,we also provide you with the opportunity to work independently and takeon responsibility from an early stage. We stand for many and variedcareer options and invest in your further development.
DEKRA has been a reliable partner for more than 90 years and ensuressafety on the road, at work and at home. As one of the world’s leadingexpert organizations, the company currently employs almost 44,000 peoplein approximately 60 countries on all five continents. With qualified andindependent expert services, they work to achieve the company's visionthat DEKRA will be the global partner for a safe world.