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Quidel Corporation Production Process Engineer 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 Production Process Engineer provides direction and support to the manufacturing area utilizing industry standard problem-solving skills and acquired scientific/engineering knowledge to resolve manufacturing issues that impact product quality and delivery. Key activities include, but are not limited to, monitoring of current manufacturing processes, reduction of variation, control/mitigation of process drift, leading / supporting troubleshooting investigations, implementing manufacturing process improvements, assessing feasibility of new manufacturing technology, ensuring manufacturing process robustness, revising/creating new documentation for Manufacturing (manufacturing instructions, routings, bills of material, SOPs, etc.), validation of new or improved manufacturing processes and equipment and integrating new products from R&D into manufacturing. This role is located in Athens, Ohio. The Responsibilities Identifies and owns process improvement initiatives related to production throughput, product yield, labor efficiency, product quality and OEE performance. Characterizes, optimizes, validates and completes ECOs for manufacturing processes to improve value stream performance. Lead CAPA and NCMR investigation processes (RCFA, 5 Why, Cause & Effects, DOE, Cause Mapping) and supports Quality Engineers in the execution of defined corrective actions. Coordinates failure investigation and deviation requests with Production Science & Quality Engineering team members. Supports the internal auditing of manufacturing processes by working with a cross-functional team to document findings and explore corrective actions. Oversees new product & process development for operations during the transfer to manufacturing. Tests and verifies new product manufacturing specifications per R&D requirements. Develops manufacturing processes, QC methods and demonstrates process feasibility using prototype equipment for new product launches. Determines if manufacturing scaleup and quality requirements are obtainable during new product transfer from R&D. The Individual Required: Bachelor's degree in engineering, life sciences, biotechnology or operations or an equivalent combination of education and experience. Experience with Quality Management Systems Direct experience with production planning and scheduling process Proven track record of project management Strong analytical capability and communication skills Knowledge of techniques for effectively maximizing manufacturing, testing & distribution process of finished goods Ability to be successful in influencing leaders, peers, and cross functional team members to work together to define issues, develop plans and implement actions on projects Ability to identify and correct complex problems by reviewing related information to develop and evaluate options and implement solutions Proven leadership skills with proven ability to facilitate effective cross-functional business improvement

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