Global QA Specialist managing the quality of IVD medical devices manufacturing for Grifols. Harmonizing quality systems, ensuring compliance, and supporting audits.
Responsibilities
Harmonize the Quality Management System across different Grifols Diagnostic in vitro diagnostic medical devices manufacturing plants.
Ensure compliance with Corporate Grifols Quality policies and procedures.
Support Quality Compliance, including audits and inspections, Distribution Quality Management, third-party evaluation and monitoring and QMS implementation and maintenance.
Establish Data Integrity policies and procedures.
Create and maintain Global SOPs for Quality Management.
Implement and manage Global Quality Management System software tools (Document Controls, Non-Conformities, CAPA, Change Control, etc.).
Establish, collect, and analyze Quality Key Performance Indicators (KPI).
Perform internal and supplier audits.
Establish and maintain Distribution Quality Management processes and Good Distribution Practices (GDP) for Grifols Diagnostic products.
Manage Non-Conformities, CAPA, and Change Control affecting different manufacturing plants or Global Quality processes.
Evaluate Quality Regulations to assess their impact on the QMS and establish implementation plans to ensure compliance.
Requirements
Bachelor’s degree in Health Sciences or Engineering.
At least 2 years of experience in a similar role, preferably in IVD medical devices Quality Management.
Strong background in quality processes within medical devices or pharmaceutical industries.
Advanced Spanish and English communication skills.
Availability to travel occasionally.
Benefits
Flexibilidad para U Program: Hybrid Model.
Flexible schedule: Lunes-Jueves 7-10 a 16-19h y Viernes 8-15h
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