EMEA Quality Integration Leader — Regional Impact

Becton Dickinson; Erembodegem; Sur place; EUR 106 000 - 161 000; Plein temps

Résumé du poste

Becton, Dickinson, and Company in Belgium seeks an EMEA Regional Quality Integration Leader to coordinate quality integration activities across Europe, the Middle East and Africa, ensuring regulatory compliance and BD standards after mergers or major changes.

Lead regional QMS integration, perform gap analyses against ISO 13485, MDR/IVDR, harmonize documentation and training, mentor cross‑functional teams, and report progress to regional leaders and global quality teams.

Qualifications

• Minimum 8–10 years of QA experience in medical devices or pharmaceutical industry.
• At least 3–5 years in a leadership/management role.
• Experience guiding quality system integrations during mergers/acquisitions.
• Strong knowledge of ISO 13485, EU MDR, IVDR, FDA QSR.
• Excellent communication and cross‑functional collaboration.
• Willingness to travel 40–50%.

Responsabilités

• Develop regional quality integration strategies aligned with global objectives and local regulations.
• Guide cross‑functional teams through QMS integration for acquired entities or major changes.
• Conduct gap analyses against BD standards and applicable regulations.
• Harmonize quality documentation, training programs and metrics.
• Act as primary contact for quality integration with regional leaders and global teams.
• Ensure effective change management to support integration initiatives.
• Monitor progress and mitigate risks.
• Participate in due diligence for potential acquisitions from a quality perspective.
• Mentor regional teams on integration challenges.
• Foster a culture of continuous improvement and quality excellence.

Connaissances

Quality leadership

Regulatory knowledge

ISO 13485

MDR/IVDR

CAPA

FMEA

Lean

Cross-functional

Formation

Bachelor's degree

Master's preferred

Outils

QMS

CAPA tools

Description du poste

Becton, Dickinson, and Company in Belgium seeks an EMEA Regional Quality Integration Leader to coordinate quality integration activities across Europe, the Middle East and Africa, ensuring regulatory compliance and BD standards after mergers or major changes.

Lead regional QMS integration, perform gap analyses against ISO 13485, MDR/IVDR, harmonize documentation and training, mentor cross‑functional teams, and report progress to regional leaders and global quality teams.