Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong. J ob Summary The mission of this position is to guarantee that the Standards under which the Quality System is based are aligned with the requirements of the different Regulations of the Countries and Organizations where Biokit sells the products. Assure that all products manufactured at Biokit are designed, manufactured and released according to established procedures. In addition this role works with specific manufacturing teams to drive continuous improvement of Quality within manufacturing – seeking defect rate reduction,



increased manufacturing efficiency,reduced costs and enhanced customer satisfaction. Key Accountabilities Review and approval of manufacturing and general procedures Development of Quality Improvement plan for manufacturing area of responsibility Measurement and reporting of Quality KPIs and metrics for manufacturing area of responsibility. Change Management: evaluate the impact of the proposed changes and management of change control. Validation: Be able to establish a strategy to validate changes. Review and approve validation strategies and the corresponding documentation (protocol and report). Risk Assessment: perform, review and approve the risk assessment performed at Biokit to evaluate the impact of changes and non-conformances in the final product. Participate in Internal and External Audits. Perform Quality Training to all personnel at Biokit. Management of Non-Conformities and CAPA. Review of product Batch Re

📌 Quality Engineer (Cataluña)
🏢 Actual Talent
📍 Cataluña