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 Supplier Quality Engineer interacts with the Company's suppliers on matters related to product quality. This position maintains and improves the Company's Supplier Management System which includes supplier qualifications, supplier audits, supplier corrective action process and scorecards. Leads complex root cause failure investigations and troubleshooting of customer complaints and product nonconformances within manufacturing. This position will also support incoming inspection in a technical capacity related to inspections. Acts as the champion of Quality System compliance. This role is located in Athens, Ohio. The Responsibilities Evaluates suppliers for technical capability and quality system performance. Leads and positively influences product improvements of supplied products through effective use of the Company's quality system. Leads the site effort in managing the nonconforming material functions through effective identification, segregation, technical root cause failure analysis and disposition of material. Resulting in sound corrective action at the supplier site to prevent reoccurrence. (SCAR System Administration) Actively reviews existing Raw Material Specifications, supplier capability, and the corresponding Receiving Inspection Instructions for accuracy and applicability. Supports (including leading as needed) root cause failure investigation activities. Writes/edits/approves investigation reports. Participates in Complaint Committee meetings and present investigation findings to peers and management. Represents the Quality Control department in evaluating failures, performing technical root cause analysis and developing and executing corrective and improvement actions. Performs statistical analysis of data from experiments and manufacturing process trend monitoring. Attends and actively participates in Management Review Board and presents findings and recommendations. The Individual Required: 3-5 years' experience in Quality and Manufacturing Systems in Medical Device and high-volume manufacturing environments, with a minimum 3 years' experience in Supplier Quality Engineering. Supplier Quality skills and experience including auditing, performance management and SCAR management. Problem Solving Methodologies/Process Capability / ISO 13485 / Design of Experiments / Sampling Plans. Experiences in providing leadership to technical teams and the use of problem-solving methodologies such as DMAIC, Ishikawa, Kepner / Tregoe etc. Strong technical aptitude and experience is a required, level of technical writing skills and abilities. Excellent communication skills Medical Device Manufacturing experience Ability to communicate effectively with all levels of employees throughout the organization. Able to develop and maintain strong working relationships with internal and external customers. Experience interacting with Regulatory Bodies (FDA, ISO) Proficient in Microsoft Office, statistical software programs, operating sy