Quality Systems Lead – Maternity Cover (Medical Devices)

Ecolab; Barcelona; Presencial; EUR 70.000 - 95.000; Jornada completa

Descripción de la vacante

Ecolab seeks a Quality System Manager to join the Healthcare Europe Quality team for a temporary maternity cover (Oct 2026–Mar 2027). You will ensure MDR 2017/745 and ISO 13485:2016 compliance across Europe while sustaining continuity of key quality processes.

Reporting to the Quality Director HC Europe, you will lead CAPA, audits, MOC, training, and management reviews, coordinating with Regulatory Affairs, Manufacturing, and RD&E to drive continuous improvement.

Formación

• 5+ years of experience in Quality Management Systems within a regulated industry.
• Experience in Medical Devices, Healthcare or similar regulated environment.
• Experience managing CAPA, audits, document control and change management.
• Project management experience preferred.

Responsabilidades

• Manage Non-Conformity System and CAPA program, ensuring timely closure.
• Lead and coordinate the audit program, including internal, supplier and external audits.
• Oversee Legal Manufacturer Change Management (MOC) processes.
• Identify quality gaps and drive KPI-driven improvements.
• Lead Management Review activities and preparation of reports.
• Coordinate training related to QMS requirements and compliance.
• Ensure audit readiness and continuity during maternity cover.
• Drive harmonization and continuous improvement across Healthcare Quality Systems.
• Collaborate with Regulatory Affairs, Manufacturing, Supply Chain, Marketing, RD&E, and cross-functional teams.

Conocimientos

Quality Mgmt Systems

CAPA management

Internal audits

Stakeholder management

English communication

Audit coordination

Educación

Bachelor's degree in Chemistry, Pharmacy, Engineering, Life Sciences, or related field

Lead Auditor certification or ISO certification training

Herramientas

ISO 13485

MDR knowledge

Audit management tools

Descripción del empleo

Ecolab seeks a Quality System Manager to join the Healthcare Europe Quality team for a temporary maternity cover (Oct 2026–Mar 2027). You will ensure MDR 2017/745 and ISO 13485:2016 compliance across Europe while sustaining continuity of key quality processes.

Reporting to the Quality Director HC Europe, you will lead CAPA, audits, MOC, training, and management reviews, coordinating with Regulatory Affairs, Manufacturing, and RD&E to drive continuous improvement.