Global Distribution Quality Leader

Integra LifeSciences Corporation; Saint-Priest; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Integra LifeSciences Corporation in France seeks a Senior Quality Specialist, Distribution to ensure harmonized quality processes across international distributors and external products handled by Integra France. You will support QMS activities, audits, and regulatory compliance for medical devices in EMEA.

The role emphasizes collaboration with European and US teams, overseeing distributor quality agreements, non-conformities, CAPAs, and post-market surveillance, with travel required.

Qualifications

• Bachelor’s degree in LifeSciences or related field.
• 5–7 years in Quality Assurance functions or at least 5 years in a Quality role.
• Strong knowledge of ISO13485, ISO9001 and Medical Device regulations.

Responsabilités

• Define and maintain distributor lists with active Agreements and ensure DQA signing.
• Support sales/ops with new distributors, draft/review distributor quality agreements.
• Manage quality records, audits, QMS activities, and regulatory compliance across EMEA.

Connaissances

Quality Assurance

ISO 13485

Project management

Audit skills

English fluency

Regulatory knowledge

Formation

Bachelor in LifeSciences

Master in Quality

Advanced degree

Description du poste

Integra LifeSciences Corporation in France seeks a Senior Quality Specialist, Distribution to ensure harmonized quality processes across international distributors and external products handled by Integra France. You will support QMS activities, audits, and regulatory compliance for medical devices in EMEA.

The role emphasizes collaboration with European and US teams, overseeing distributor quality agreements, non-conformities, CAPAs, and post-market surveillance, with travel required.