EMEA Regional Quality Integration Leader

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

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

About the Role

The EMEA Regional Quality Integration Leader will be responsible for leading and coordinating quality integration activities across the Europe, Middle East, and Africa regions, ensuring adherence to regulatory requirements and internal quality standards following mergers, acquisitions, or significant process changes. This is an outstanding opportunity to develop the quality landscape of our organization in a region that spans multiple countries and regulatory environments.

Main Responsibilities will include

• Develop and carry out regional quality integration strategies and plans that align with global quality objectives and local regulatory frameworks.
• Guide cross-functional teams through the integration of quality management systems (QMS), processes, and procedures for newly acquired entities or major business changes within the EMEA region.
• Conduct gap analyses of existing quality systems against BD standards and applicable regulations (e.g., ISO 13485, MDR, IVDR), developing and implementing remediation plans.
• Harmonization of quality documentation, training programs, and quality metrics coordinated across integrated sites.
• Act as the primary point of contact for quality integration matters with regional business leaders, global quality teams, and regulatory affairs.
• Ensure effective communication and change management strategies are in place to support successful quality integration.
• Monitor and report on the progress of quality integration initiatives, identifying and mitigating potential risks.
• Participate in due diligence activities for potential acquisitions from a quality perspective.
• Provide expert mentorship and support on quality integration challenges to regional teams.
• Foster a culture of continuous improvement and quality excellence throughout the integration process.

About you

• Bachelor's degree or equivalent experience in a scientific, engineering, or related field. Master's degree preferred.
• Minimum of 8-10 years of experience in Quality Assurance in the medical device or pharmaceutical industry. At least 3-5 years must be in a leadership or management role.
• Established background in guiding and handling quality system integrations associated with mergers, acquisitions, or substantial organizational shifts.
• Comprehensive understanding of applicable medical device regulations (e.g., ISO 13485, EU MDR, IVDR, FDA QSR).
• Solid knowledge of quality management concepts, tools, and approaches (e.g., CAPA, FMEA, lean manufacturing).
• Proven capability to guide and impact cross-functional teams within a complex, matrixed organization.
• Excellent communication, interpersonal, and presentation skills with the ability to engage collaborators at all levels.
• Strong analytical and problem-solving abilities.
• Fluency in English required; proficiency in other major European languages (e.g., German, French) is a significant advantage.
• Willingness to travel regularly throughout the EMEA region (up to 40-50%).

This role is perfect for someone who thrives in a dynamic environment and is excited by the challenge of integrating quality systems across diverse regions and cultures. Join us and be a part of a team that is committed to clinical excellence and patient safety!

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

BEL Erembodegem - Dorp 86

Additional Locations

POL Warsaw - ul. Cybernetyki

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Salary Range Information

€105,800.00 - €161,375.00 EUR Annual