EMEA Quality Integration Leader

BD; Województwo mazowieckie; On-site; PLN 464,000 - 708,000; Full time

Job summary

BD is seeking a seasoned Quality Integration Leader to drive regional quality integration strategies across the EMEA region. You will guide cross-functional teams through QMS integrations for newly acquired entities and major business changes, aligning with ISO 13485, MDR, IVDR and FDA QSR.

The ideal candidate has 8–10 years in QA in medical devices/pharma, with 3–5 years in leadership, and strong change management abilities. Willingness to travel up to 40–50% is required.

Qualifications

• Minimum 8–10 years in Quality Assurance in the medical device or pharmaceutical industry.
• At least 3–5 years in a leadership or management role.
• Experience guiding quality system integrations for mergers, acquisitions, or major organizational shifts.
• Strong knowledge of ISO 13485, EU MDR, IVDR, FDA QSR.

Responsibilities

• Develop regional quality integration strategies aligned with global objectives.
• Guide cross-functional teams through QMS integrations for newly acquired entities or major changes.
• Conduct gap analyses against BD standards and applicable regulations (ISO 13485, MDR, IVDR, FDA QSR).
• Harmonize quality documentation, training, and metrics across integrated sites.
• Act as primary contact for quality integration with regional leaders, global quality teams, and regulatory affairs.
• Ensure effective communication and change management for quality integration.
• Monitor and report progress, identifying risks and remediation actions.
• Participate in due diligence activities from a quality perspective.
• Provide mentorship on quality integration challenges to regional teams.
• Foster culture of continuous improvement and quality excellence.

Skills

Quality leadership

Regulatory knowledge

Cross-functional leadership

Quality system integrations

CAPA

FMEA

Lean manufacturing

Communication

Problem-solving

Travel readiness

Education

Bachelor's degree

Master's degree preferred

Tools

ISO 13485

Job description

BD is seeking a seasoned Quality Integration Leader to drive regional quality integration strategies across the EMEA region. You will guide cross-functional teams through QMS integrations for newly acquired entities and major business changes, aligning with ISO 13485, MDR, IVDR and FDA QSR.

The ideal candidate has 8–10 years in QA in medical devices/pharma, with 3–5 years in leadership, and strong change management abilities. Willingness to travel up to 40–50% is required.