Quality System Manager (Temporary contract)
Core
Ensure Ecolab's Healthcare Europe Quality Management Systems remain compliant with MDR 2017/745 and ISO 13485:2016 regulations while providing continuity during a temporary maternity cover period.
Role type
Quality System Manager (Temporary Maternity Cover)
Builds
Quality Management Systems for Medical Devices and Healthcare products in Europe
Domain
Medical Devices / Healthcare / Regulatory Compliance
Required skills
CAPA program management, audit program leadership, Legal Manufacturer Change Management (MOC), stakeholder engagement, KPI tracking, Management Review preparation, training coordination
Preferred skills
Lead Auditor certification, Project management
Technologies
ISO 13485, ISO 9001, MDR 2017/745
Responsibilities
Manage the Non-Conformity System and CAPA program; Lead and coordinate internal, supplier, and external audits; Oversee the Legal Manufacturer Change Management (MOC) process; Engage stakeholders to identify quality system gaps and drive improvement via KPIs; Lead Management Review activities and prepare performance reports; Support and coordinate training activities related to QMS requirements; Ensure audit readiness and continuity of compliance activities; Drive harmonization and continuous improvement initiatives across Healthcare Quality Systems.
Seniority
Mid-Senior, hands-on IC