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summary

diegem
contract
40 hours per week

group function
medical
reference
CXRSP-110482

job details

As Quality Systems Coordinator, you will provide support to the CSS EUDAMED franchise leader in the end-to-end operational launch readiness and implementation of this new European medical device database and work together with the Franchise Forum members (core team consisting of SMEs from the different functional areas) on all quality related activities for data collection, data validation and data transfer to the EUDAMED system to ensure accuracy, consistency and completeness.Interested? Email your resume to bianca.dardenne@professionals.randstad.be

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key responsibilities
- Coordinate quality (QMS) related activities, e.g. identification of affected procedures and work with CSS operating companies in updating them, assigning training, etc. as part of the rollout of the new requirements.
- Support the CSS operating companies and their quality groups in developing triggers to manage changes (of data/attributes) and to maintain them in the most effective and efficient manner.
- Together with the Franchise Lead and the PMO/Project Coordinator, as part of these activities, effectively absorb requirements, communicate risks and issues and increase the likelihood of project success (go live)
- Work with SME to ensure that all relevant EUDAMED policies, processes, systems and procedures are identified, catalogued, documented, released and followed by each functional team. This includes both shared procedures and procedures that are franchise specific.
- Coordinate implementation plan activities that bring the franchise fully live and in compliance with EUDAMED, based on the strategy outlined by the EUDAMED program and core teams.
- Follow the documentation standards requested by the EUDAMED program or core teams.
- Participate in EUDAMED program status meeting or core team as requested.
- Support internal/external audits of EUDAMED-related processes as requested.
qualifications
- Bachelor's or Master's degree in medical/pharmaceutical/natural/biological sciences, engineering or similar qualification.
- Minimum of 2 quality, compliance and/or regulatory experience in the medical device or pharmaceutical industry.
- Qualification as a QMS auditor would be good
- Interest in data/analyses/flows/systems
- Good communication and presentation skills
- Fluent in English (written and oral)
key benefits
In response to your high performance & flexibility, Randstad Professionals offers you an interesting salary package, with some interesting perks such as:
Meal vouchers of €7
Net representation expenses of €80
Hospitalization insurance
Car + unlimited fuel card OR mileage reimbursement
32 vacations
End of year bonus
Pension plan
ECO vouchers
Training opportunities

about the employer

Diversity, Equality & Inclusion:

For over 130 years, diversity, equality & inclusion have been part of the cultural fabric and woven into how they do business every day. Their commitment to respect the dignity and diversity of all is embedded in their credo.

They know that the success of their business depends on the best talent in a workforce that reflects the diverse markets they serve globally and an inclusive culture that values different perspectives and life experiences.

That's why in Belgium we work to create an inclusive environment where different backgrounds, perspectives and experiences are valued and each of our people feels they belong and can reach their potential. Whoever they are. Diversity, Equity & Inclusion means "You Belong."

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Diversity, Equality & Inclusion:

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