Job Information
Quidel Corporation Manager, Production Engineering in Athens, Ohio
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 Manager, Production Engineering responsible for the development and implementation of engineering strategies and tactics supporting QuidelOrtho' s corporate objectives. This position functions as the primary facility subject matter expert while overseeing and managing daily engineering activities in support of the value streams manufacturing goals to meet overall company objectives. The role is instrumental in leading efforts such as new product development, process improvement, equipment reliability, capital projects, and ensures world class processes related to the accuracy and development of production data/technical information. This role is located in Athens, Ohio. The Responsibilities Provide strategic guidance and daily leadership for value stream engineering team (Process Engineering, Equipment Technicians, Automation Engineers, Technical Writer, and Production Data Specialist). Collaborate on root cause investigations and corrective actions throughout the manufacturing process as it relates to operational performance. Performs feasibility studies, scope development, capital requests (CERs), and oversees the execution of cost & capital projects within respective value stream. Oversight and execution of all asset management (financial tracking & reporting, calibrations, and related preventative maintenance [internal/contracted]) on all assets specific to the individual's respective business. Maximize process equipment availability/performance/quality and creates a metric (OEE) driven manufacturing environment targeted at identifying process trends and proactively implements continuous improvement initiatives to meet business objectives. Manages equipment design & reliability, process engineering, and data integrity from chemistry through final production assembly for respective value stream. Responsible for initiating and executing "existing" (repair/relocation) equipment validation protocols (IQ, OQ, PQ) and reports per (GSOP) Oversight of all data and technical documentation related to operations and ERP system. Which includes, integrity of established manufacturing Instructions (MI's), development and implementation of MFG documentation for new products and processes, including TMs (Test Methods), MIs (Manufacturing Instructions), development of equipment operating procedures (EOPs, SOP's, & JSP's) and changes per ECO process., and approve BOM's (Bill of Materials) manufacturing routings and execute changes as required. Initiate change orders relating to Equipment & Process Manufacturing Instructions and collaborates on initial protocol and revisions. Actively manages, and advises adjustments to LBE/AOP as needed, departmental expenses and manpower allocations within the site budget and to achieve strategic objectives. Defines and oversees the execution of the preventative maintenance strategy for respective (new and existing) assets. Demonstrates commitment to the development, implementation, and effectiveness of Quality Management System per ISO, FDA, and other regu