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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce, and market innovative medicines, solutions, and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We are hiring a Global Quality Specialist to join our Diagnostic Global Quality department. This role will be responsible for managing the global quality of our in vitro diagnostic medical devices manufacturing plants.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, 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 (KPIs).
* 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.
Qualifications:
* 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.
* Ability to work effectively both independently and as part of a team.
* Availability to travel occasionally.
What we offer:
This is a brilliant opportunity for you. Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at [website link].
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