QualityEngineeringOptimisationManager

## The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. **_Quality Engineering Optimisation Manager_** We’re recruiting for a Quality Engineering Optimisation Manager to join our team based in Pencoed. This role will report to the Senior Manager, Quality Engineering Excellence. **_Your new role:_** As the Quality Engineering Optimisation Manager, you will provide direction and operational oversight across Quality Engineering, ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). You will be responsible for leading and developing a team of Quality Engineers focused on continuous improvement and optimisation of manufacturing and quality processes for in vitro diagnostic (IVD) medical devices. The role ensures robust implementation of Corrective and Preventive Actions (CAPA), validation activities, and process improvement initiatives to maintain compliance with regulatory requirements while improving product quality, operational efficiency, and reliability. The Quality Engineering Optimisation Manager works cross-functionally to embed Quality and Compliance principles across the product lifecycle, supporting inspection readiness and operational excellence. Ensu