Senior Process Engineer

QuidelOrtho is a powerful collaboration between Quidel Corporation and Ortho Clinical Diagnostics, forming a premier global entity in the field of in vitro diagnostics. We excel in the development and manufacturing of immunoassay and molecular testing, clinical chemistry, and transfusion medicine products. With a workforce exceeding 6,000 employees and operations extending to over 130 countries, we deliver fast, accurate, and reliable diagnostic testing solutions spanning from hospital settings to home use. Our company culture emphasizes the well-being of our employees by fostering an environment that encourages happiness, inspiration, and engagement. We believe that the success of the business is intrinsically linked to the happiness and meaningful connections of our team members. We invite you to join us in making a significant impact on global health through the transformative power of diagnostics.

The role of Senior Process Engineer at QuidelOrtho is a pivotal position dedicated to advancing manufacturing excellence in diagnostic reagents and related products. Located onsite in Carlsbad, CA, this role entails providing critical leadership and technical expertise to the manufacturing area by applying scientific and engineering knowledge to resolve complex production challenges that can affect product quality and delivery schedules. The Senior Process Engineer will be deeply involved in monitoring and optimizing manufacturing processes, reducing variability, and ensuring that processes are robust and capable of consistently producing high-quality products. The position demands a hands-on approach to troubleshooting, implementing process improvements, and validating new or enhanced manufacturing processes and equipment. A significant aspect of the job is to support the integration of new products from research and development into full-scale manufacturing, ensuring smooth product scale-up and production readiness.

Additionally, the role requires collaboration with multiple cross-functional teams including R&D, Quality, Operations, Regulatory Affairs, and Supply Chain to shape and standardize process specifications that meet both business goals and regulatory compliance. The Senior Process Engineer will lead continuous improvement initiatives using Lean and Six Sigma methodologies to increase operational efficiency, reduce waste, and elevate product quality. They will assume responsibility for leading technical investigations of manufacturing deviations, nonconformances, and failures to promptly identify root causes and implement corrective actions that mitigate risks and prevent recurrence.

This role also encompasses the responsibility for overseeing and supporting audits, both internal and external, by assessing process performance, identifying gaps, and ensuring that corrective and preventive actions are effectively implemented. The Senior Process Engineer will serve as a mentor within the Process Engineering team, fostering an innovative and accountable culture focused on continuous improvement. This position offers a competitive salary range from $102,360.25 to $130,000 annually and is part of a comprehensive benefits program including medical, dental, vision, life, and disability insurance, along with 401(k), employee assistance programs, stock purchase plans, paid time off, and holidays. Join QuidelOrtho and contribute to shaping the future of diagnostics with meaningful work that saves lives and improves health worldwide.