Medical Device Quality Manager

il y a 4 semaines


Paris, Île-de-France Balt Temps plein
Join Balt as a Quality System Lead

Balt, a leading medical device company, is seeking a highly skilled Quality System Lead to join our team. As a Quality System Lead, you will be responsible for the management of Quality System elements, including monitoring of system performance, training, and regulatory watch.

Key Responsibilities:

  • Act as a Subject Matter Expert (SME) for listed processes and coordinate site committees to ensure best follow-up
  • Define relevant KPIs and ensure adequate reporting to site leadership
  • Lead projects to improve the Quality System through Change Control Processes
  • Develop and execute 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
  • 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)
  • Provide necessary training to stakeholders once required
  • Participate to the Management Reviews as SME

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 ISO 13485:2016, European MDR
  • Lead auditor certification to ISO 13485:2016 is ideal

Balt is a global neurovascular platform that has been leading the way for 45 years. We collaborate with physicians and institutions to develop elegant medical devices that are used by physicians across the world. Our products are being used in 11 countries, and we have 13 offices worldwide. 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 a Quality System Lead, you will be part of a team that is always seeking to expand beyond boundaries and bring innovation to the peripheral vascular space. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.


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