EMEA Quality Integration Lead

BD; Aalst; On-site; EUR 106,000 - 161,000; Full time

Job summary

BD is recruiting an EMEA Regional Quality Integration Leader to drive quality integration across Europe, the Middle East and Africa after mergers or major changes. You will lead QMS integration, gap analyses and remediation while harmonizing documentation and training across sites.

Ideal candidates have 8–10 years in QA in medical devices/pharma, 3–5 years in management, strong regulatory knowledge, and willingness to travel up to 40–50% across the EMEA region.

Qualifications

• Bachelor's degree or equivalent in scientific/engineering field; Master’s preferred.
• 8–10 years of QA in medical device or pharma; 3–5 years in leadership.
• Experience guiding quality system integrations in mergers, acquisitions, or major changes.
• Solid knowledge of ISO 13485, EU MDR, IVDR, FDA QSR.
• Knowledge of QA tools: CAPA, FMEA, lean manufacturing.
• Ability to lead cross-functional teams in a matrixed organization.
• Excellent communication and presentation skills; English fluency required.

Responsibilities

• Develop regional quality integration strategies aligned with global quality objectives.
• Lead QMS integration for acquired entities or major changes in the EMEA region.
• Conduct gap analyses against BD standards and regulations; implement remediation.
• Harmonize documentation, training, and quality metrics across sites.
• Serve as point of contact for quality integration with leaders and regulatory affairs.
• Communicate effectively and manage change to support integration."},
• CoT_job_summary_short
• BD
• KEY POINTS: Quality integration leadership across EMEA; ISO13485/MDR/IVDR compliance, cross-functional impact
• job_summary_short
• <p>BD is seeking an EMEA Regional Quality Integration Leader to coordinate quality integration activities across Europe, the Middle East and Africa, ensuring adherence to regulatory requirements after mergers or major changes. You will guide cross‑functional teams through QMS integration and remediation efforts while harmonizing documentation and training across sites.</p><p>The role requires 8–10 years in QA within medical devices or pharmaceuticals, with 3–5 years in a leadership position, and strong knowledge of ISO 13485, EU MDR/IVDR, and CAPA/FMEA. Travel up to 40–50% is expected.</p>
• contract_type
• fulltime
• location_type
• on site
• remote_scope
• null
• perks
• []
• stated_min
• 105800
• stated_max
• 161375
• stated_absolute
• null
• salary_estimation_cot
• BD EMEA QA integration lead: market EUR 105,800–161,375 yearly, with regional complexity and regulatory scope.
• estimated_low
• 105800
• estimated_medium
• 133588
• estimated_high
• 161375
• currency
• EUR
• frequency
• yearly
• bonus
• null
• tax
• gross
• application_email
• null
• job_end_date
• null
• contact_person
• null
• hiring_department_name
• null

Skills

Quality leadership

Regulatory knowledge

QMS integration

ISO 13485

EU MDR/IVDR

CAPA & FMEA

Cross-functional leadership

English fluency

M&A QA

Education

Bachelor's degree or equivalent

Master's degree preferred

Tools

QMS software

CAPA tools

FMEA tooling

Job description

BD is recruiting an EMEA Regional Quality Integration Leader to drive quality integration across Europe, the Middle East and Africa after mergers or major changes. You will lead QMS integration, gap analyses and remediation while harmonizing documentation and training across sites.

Ideal candidates have 8–10 years in QA in medical devices/pharma, 3–5 years in management, strong regulatory knowledge, and willingness to travel up to 40–50% across the EMEA region.