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QMS Specialist / Lead – F/H

Type de contrat : CDI
Région : Île-de-France
Rémunération : entre 60K€ et 70K€
Famille de métier : Réglementaire

Présentation société

Balt est une entreprise française, fabricante de matériel médical, basée à Montmorency (Val-d’Oise). Elle est spécialisée dans les dispositifs médicaux dédiée au traitement des maladies vasculaires du cerveau, notamment des accidents vasculaires cérébraux (AVC).

About Balt

Our purpose is to improve the lives of 150,000 patients in 2026.

 

Our story

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world\'s broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.

 

Why Join Balt? Join a passionate team, dedicated to making a difference.

Working at Balt means giving meaning to your work! Pride is a strong part of our identity.

We are a close-knit team, with strong mission, vision and values that guide our day-to-day.

Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.

No matter the country, we take care of you.

Would you like to be part of our story? Don\'t hesitate, come and join us!

 

 

About the Opportunity

Provide support on the maintenance, development, and control of the Quality system. This mission also includes the evaluation of the current QMS according to the applicable standards and the implementation of the new medical device regulation 2017/745. You participate in continuous improvement projects and ensure the organization\'s compliance with regulatory requirements.

 

Job responsibilities: 

  • Is responsible for the management of Quality System elements including monitoring of system performance (Documents & records control; Training; Regulatory Watch)
  • Act as a SME for the listed processes and coordinate site committees to ensure the best follow-up
  • Define the relevant KPIs and ensure an adequate reporting to the site leaderships
  • Lead projects to improve the Quality System through Change Control Processes
  • Development and execution of cross-functional process and system improvements to improve Quality, Compliance, and Service Level to customers
  • Participate/support in QMS Project Planning
  • Maintenance and improving the mapping of the current QMS/ Evaluation of the consequences of QMS modifications in terms of quality (organization, documentation, validation, training, premises, investments, suppliers...)
  • Participate to worldwide QMS communities as part of project of harmonization and global monitoring
  • Participate and/or carry out internal and external audits (ensure that identified corrective actions are carried out, prepare and participate in national authorities\' inspections)
  • Participate in NCA inspection and NB audits
  • Provide necessary training to stakeholders once required
  • Participate to the Management Reviews as SME

 

 

Descriptif du profil

Qualification requirements:

  • Master\’s degree in a scientific discipline
  • Minimum of 7-10 years\’ experience in Medical Device Industry (Quality, Regulatory or related function)
  • Fluent in English
  • Excellent technical written and verbal communication skills
  • Experience with creating/integrating Quality Systems
  • Experience with Transitional MDR requirements implementation
  • Strong knowledge of IS013485:2016, European MDR o Lead auditor certification to IS013485:2016 is ideal

 

Postuler

Balt Group
recrutement@baltgroup.com



Dernière mise à jour : 13/06/2024