Senior Process Engineer

Quidel Ortho 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.

At Quidel Ortho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Process Engineer. This position provides direction and support to the manufacturing area utilizing structured 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 position will be onsite in Carlsbad, CA.

• Provide technical and strategic leadership in the design, development, and optimization of manufacturing processes for diagnostic reagents and related products, ensuring scalability, robustness, and long-term operational excellence.

• Lead cross-functional collaboration with R&D, Quality, Operations, Regulatory, and Supply Chain to define, refine, and standardize process specifications that align with business objectives and compliance requirements.

• Drive continuous process improvement initiatives, leading efforts to characterize, optimize, validate, and implement Engineering Change Orders (ECOs) to enhance efficiency, reduce variability, and strengthen process capability.

• Own and lead technical investigations related to NCMRs, CAPAs, deviations, and failure analyses within the Chemistry Manufacturing area, ensuring timely root cause identification, risk mitigation, and sustainable corrective actions.

• Lead/support internal and external manufacturing audits, partnering with cross-functional stakeholders to assess process performance, identify gaps, and implement effective corrective and preventive actions.

• Serve as the process engineering lead in R&D-to-Manufacturing transfer activities, guiding scale-up strategies, assessing production readiness, and ensuring seamless integration into commercial manufacturing.

• Champion adherence to the Quality Management System, modeling compliance excellence and reinforcing alignment with business policies, regulatory standards, and industry best practices.

• Drive Lean and Six Sigma deployment, mentoring team members and leading structured improvement projects to elevate product quality, increase throughput, and strengthen operational efficiency.

• Act as a technical mentor and thought leader within the Process Engineering function, elevating team capability and fostering a culture of accountability, innovation, and continuous improvement.

• Performs other duties & projects as assigned

Required:

• Bachelor's degree in chemical engineering or related field.

• Minimum of 8-10 years' experience in process engineering, with a background in the fields of diagnostics, biochemistry, or immunochemistry.

• Experience with regulatory compliance standards (e.g., FDA, ISO).

• Good problem-solving skills, including root cause analysis and data driven…