Senior Q&C Specialist - Medical Devices (EMEA)

Johnson & Johnson Co.; Machelen; Híbrido; EUR 76.000 - 96.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

12-month contract

Descripción de la vacante

Johnson & Johnson MedTech is seeking a Senior Quality and Compliance Specialist to support the EMEA EP organization from the European HQ in Diegem, Belgium. You will lead CAPA/NCR activities, act as Field Action Coordinator, and support audit readiness and regulatory requests.

The role requires 4–5 years in a regulated medical device environment, knowledge of EU MDR, ERP/QMS experience, and strong English skills. Hybrid work: 3 onsite days, 2 remote days; 12-month contract.

Formación

• Bachelor's degree in a scientific field; 4–5 years in regulated medical devices.
• Knowledge of EU MDR 2017/745 and European regulatory environment.
• Experience with CAPA, NCR investigations, root-cause analysis and CAPA closure.
• ERP and electronic QMS experience for CAPA, NCR, audits and training records.
• Experience with Field Actions: Holds, Stop Shipments, recalls.
• English proficiency; additional languages a plus.

Responsabilidades

• Lead CAPA and NCR investigations and develop effective solutions.
• Act as Field Action Coordinator for Holds, Stop Shipments, recalls.
• Coordinate audit readiness and support audits; close audit observations.
• Support regulatory and quality compliance activities with Health Authority requests.
• Oversee DC rework activities; ensure procedures are followed.
• Inspect returned products at the Distribution Center as required.
• Collaborate with cross-functional teams to resolve quality issues.
• Participate in local/global projects to improve quality processes.
• Support training and retention documentation for the department.

Conocimientos

CAPA investigations

NCR investigations

Root cause analysis

Cross-functional collaboration

Problem solving

Educación

Bachelor's degree in a scientific field

Herramientas

ERP systems

Electronic QMS

Descripción del empleo

Johnson & Johnson MedTech is seeking a Senior Quality and Compliance Specialist to support the EMEA EP organization from the European HQ in Diegem, Belgium. You will lead CAPA/NCR activities, act as Field Action Coordinator, and support audit readiness and regulatory requests.

The role requires 4–5 years in a regulated medical device environment, knowledge of EU MDR, ERP/QMS experience, and strong English skills. Hybrid work: 3 onsite days, 2 remote days; 12-month contract.