Improving healthcare for millions of people worldwide is a goal we have been striving to achieve since 1909 at Grifols, a global healthcare company.
We are committed to diversity and equal employment opportunities that foster an inclusive environment.
The Diagnostic Global Quality department is hiring a Global Quality Specialist to manage the quality of our in vitro diagnostic medical devices manufacturing plants across the globe.
Your Responsibilities
* Ensure uniformity of the Quality Management System across different Grifols Diagnostic in vitro diagnostic medical devices manufacturing plants.
* Guarantee compliance with Corporate Grifols Quality policies and procedures.
* Support quality compliance, including audits and inspections, distribution quality management, third-party evaluation and monitoring, QMS implementation and maintenance, etc.
* 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.
About You
* You hold a bachelor's degree in health sciences or engineering.
* You have at least 2 years of experience in a similar role, preferably in IVD medical devices quality management.
* You possess a strong background in quality processes within medical devices or pharmaceutical industries.
* You possess advanced Spanish and English communication skills.
* You can work effectively both independently and as part of a team.
* You have availability to travel occasionally.
About Us
We recognize our employees as one of our major assets and strive to maintain an atmosphere that encourages professional growth and development in an excellent working environment.