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About the role
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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