EMEA Quality Compliance Lead – Internal Audits & QMS

Becton Dickinson; Paterna; Presencial; EUR 55.000 - 59.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Total Rewards program

Descripción de la vacante

Becton Dickinson is seeking a Quality Compliance Specialist to coordinate and execute the regional quality compliance program across EMEA, leading internal audits and supporting external audits to strengthen the Quality Management System.

The ideal candidate has a Life Sciences degree and 3–5 years in regulated QA/QMS roles, with strong knowledge of ISO 13485 and regulatory requirements. Fluency in English is required; travel within the EMEA region is expected.

Formación

• Bachelor's degree in Life Sciences, Engineering, Quality Management, or a related discipline.
• 3–5 years of experience in Quality Assurance, Quality Compliance, or Quality Systems within regulated industries (Medical Devices, Pharmaceutical, Biotechnology, or similar).
• Experience planning and conducting internal audits.
• Experience supporting external audits and regulatory inspections.
• Experience preparing management review materials and quality metrics analysis.
• Fluent in English; additional European languages are an advantage.

Responsabilidades

• Develop and maintain the annual EMEA internal audit program based on risk, regulatory requirements, and business priorities.
• Plan, conduct, document, and report internal audits across EMEA locations and functions.
• Monitor audit findings and support site management in the timely implementation and closure of corrective and preventive actions (CAPAs).
• Coordinate and support external audits, including notified body, certification body, customer, and regulatory inspections.
• Prepare and consolidate Management Review inputs and reports, ensuring accuracy, completeness, and timely delivery.
• Analyze quality metrics and trends to support Management Review discussions and decision-making.
• Support maintenance and continuous improvement of the Quality Management System in accordance with applicable regulations and standards.
• Provide guidance to functions and sites on quality compliance requirements, audit readiness, and best practices.
• Support Quality activities across the region, including CAPA management, quality risk management, document control, change management, training compliance, and quality reporting, as required.
• Collaborate with regional and global Quality teams to ensure alignment of compliance initiatives and quality objectives.
• Promote a culture of quality, compliance, and continuous improvement throughout the organization.

Conocimientos

Quality Assurance

Quality Compliance

Internal Audits

Regulatory Inspections

QMS Knowledge

Educación

Bachelor's degree in Life Sciences or related

Certified Internal Auditor

Herramientas

ISO 13485

FDA QSR

Descripción del empleo

Becton Dickinson is seeking a Quality Compliance Specialist to coordinate and execute the regional quality compliance program across EMEA, leading internal audits and supporting external audits to strengthen the Quality Management System.

The ideal candidate has a Life Sciences degree and 3–5 years in regulated QA/QMS roles, with strong knowledge of ISO 13485 and regulatory requirements. Fluency in English is required; travel within the EMEA region is expected.