Quality Coordinator

Location: Diegem, Belgium

Duration: initial for 9 months

Hours: 40h - 32h 

Hybrid way of work (one day per week on-site) 

Imagine your next role as a Quality Control Coordinator.

Responsibilities

• Provide support to CSS EUDAMED Franchise lead on the end-to-end operational launch readiness & implementation of this new European Database on Medical Devices*

• Coordinate Quality (QMS) related activities, e.g. identification of procedures impacted and work with the CSS Operating Companies in updating them, assigning trainings etc. as part of the rollout of the new requirements.

• Work with the Franchise Forum members (a core team consisting of SMEs from different functional areas) on any quality-related activities for data gathering, data validation, and data transfer to the EUDAMED system to ensure accuracy, consistency, and completeness.

• Support the CSS Operating Companies and their Quality groups in developing triggers for managing changes (of data/attributes) and maintaining them in the most effective and efficient way.

• Together with the Franchise Lead, the PMO/Project Coordinator as part of these activities, effectively absorbs requirements, communicates risks and issues, and increases the likeliness for the success of the project (go live).

• Work with SMEs to ensure all EUDAMED relevant policies, processes, systems, and procedures are identified, cataloged, documented, released, and followed by each functional team. This includes both shared procedures and those that are franchise-specific.

• Coordinate activities on an implementation plan that brings the franchise fully live and compliant with EUDAMED based on the strategy outlined by the EUDAMED Program and Core Teams.

• Follow the documentation standards requested by either the EUDAMED Program or Core Teams.

• Participate in EUDAMED Program or Core Team status meeting as requested.

• Support internal/external audits of EUDAMED-related processes as requested.

To be successful in this role you have:

• Bachelor’s or Master’s degree in medical/pharma/natural/biological Science, Engineering or similar qualification.

• At least 2 Experience in Quality, Compliance and/or Regulatory Affairs in Medical Device or pharmaceutical industry.

• Qualification as QMS auditor would be good

• Interest in data/analytics/flows/systems

• Good communication and presentation skills

• fluent in English (written and verbal)

benefits

This role offers a competitive hourly rate & a supportive working environment. This contract will run initially for 9 months. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.

about Janssen 

Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

https://www.janssen.com/belgium/nl

https://www.jnj.com/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact:  katerina.alikaridou@randstadsourceright.nl

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!