Global Manager Quality, Risk & Accreditations Management Medical
The Global Manager will collaborate with the Notified Bodies in UK, Netherlands and Germany and will be responsible for the following activities:
- Enhancing and improving the procedures together with the process owners;
- Coordinate and/or perform the internal medical audits for all DEKRA divisions and arrange training tests for effectiveness;
- Participate in the Notified Body steering committee and strengthen harmonization of QMS of all DEKRA Notified Bodies;
- Monitor key performance indicators (KPIs) for the SD and Notified Bodies;
- 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 evaluate with process owners the potential consequences for the medical device teams;
- Share process excellence / develop and conduct training;
- Support 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 the candidate will work as part of a team on the full scope of responsibilities to achieve the departmental standards.
The Manager will work together with other departments within DEKRA SD PT to identify any process improvements and improve standards, efficiency and profitability.
- MSc degree in Engineering, Science, or healthcare-related field
- A minimum of 4 years of experience in a relevant Life Science field in QA position (Medical)
- Business fluent written and spoken English
- Willingness for international travelling
- Good communication and organizational skills with an eye for detail
- Ability to take part in conversations and speak up about challenges, conflicts and mistakes
- Proactive, responsive, and inquisitive - constantly looking for ways to improve
- Preferably, Notified Body QA Medical experiencee
- 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
- French and German language skills will be an add on
Salary commensurate with experience