Quality Management Specialist

il y a 2 jours


DeuillaBarre, Île-de-France Balt Temps plein
About Balt

Balt is a pioneering company in the medical device industry, dedicated to improving the lives of patients worldwide. With a rich history spanning 45 years, we have established ourselves as a leader in developing innovative medical devices. Our products are used by physicians globally, and we have a strong presence in 11 countries with 13 offices.

Our Mission

We are committed to empowering physicians to save lives by providing elegant medical devices that meet the highest standards of quality and safety. Our mission is to improve the lives of 150,000 patients by 2026, and we are dedicated to making this vision a reality.

The Opportunity

We are seeking a highly skilled Quality Management Specialist to join our team. As a key member of our quality team, you will be responsible for the maintenance, development, and control of our Quality System. This includes evaluating our current QMS according to applicable standards and implementing the new medical device regulation 2017/745.

Key Responsibilities:
  • Manage Quality System elements, including monitoring system performance, documents, and records control, training, and regulatory watch.
  • Act as a Subject Matter Expert (SME) for listed processes and coordinate site committees to ensure effective follow-up.
  • Define relevant Key Performance Indicators (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 enhance Quality, Compliance, and Service Level to customers.
  • Participate in QMS Project Planning, Maintenance, and improvement of the mapping of the current QMS.
  • Evaluate the consequences of QMS modifications in terms of quality, including organization, documentation, validation, training, premises, investments, and suppliers.
  • Participate in worldwide QMS communities as part of project harmonization and global monitoring.
  • Participate in and/or carry out internal and external audits, ensuring identified corrective actions are carried out, and prepare and participate in national authorities' inspections.
  • Provide necessary training to stakeholders as required.
  • Participate in Management Reviews as SME.
Qualification Requirements:
  • Master's degree in a scientific discipline.
  • Minimum of 7-10 years' experience in the 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.
  • Lead auditor certification to ISO 13485:2016 is ideal.


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