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. The Role The Senior Manager, Quality Assurance is responsible for implementing and maintaining the quality management system in accordance with the Quality System Manual. This position maintains an integrated quality management system with emphasis on select systems (e.g., CAPA, Validation) and provides direction and decision-making regarding quality assurance operations. The Senior Manager, Quality Assurance provides technical leadership, guidance, and support to the site in the areas of Quality Assurance and ensures compliance to all programs, procedures, applicable regulatory, and customer requirements as well as alignment with overall strategic objectives of the department and the business. This role is located in Athens, Ohio. The Responsibilities Provides Quality functional leadership including hiring and managing a professional, high performing quality assurance staff designed to meet the technical and compliance requirements. Provides strategic planning and implementation for the Quality System, including Interpretation of MDSAP/ISO/IVD/USDA medical device regulations and guidelines to determine the impact to Quality Assurance Systems. Provides site guidance with respect to regulations, guidelines, and emerging inspectional trends. Provides compliance oversight of the various site quality tools / systems to maintain an effective, compliant and validated system (e.g. MasterControl, Complaint Handling). Directs and manages all functions within quality assurance ensuring that each function is resourced, structured and managed to support the goals of the organization. Functional areas may include, but not limited to: CAPA, Complaint Monitoring and Trending, Validation, Training. Establishes and maintains departmental budgets. Carries out duties in compliance with established business policies. The Individual Required: BS/BA or equivalent work experience Minimum of 7 years of progressively more responsible experience of quality system management in medical device and high-volume manufacturing environments. Extensive working knowledge of quality system requirements including ISO, MDSAP, IVD regulations and have a proven track record of successfully implementing these requirements. Experience with document management systems. Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines. Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously. Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication. Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others. Demonstrated ability to successfully interact with regulatory health authorities at inspections (prior experiencing leading inspections is a must). Proficient in Microsoft Office suite of products (Word, Excel, PPT). Knowledge of process-based risk manag