Senior Process Engineer

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.

At QuidelOrtho, 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 decision making.

• Excellent teamwork and communication skills.

• Knowledge of statistical tools and data analysis software such as JMP, Excel and Minitab.

• Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts)

• This position is not currently eligible for visa sponsorship.

Preferred:

• Experience in lateral flow technology preferred.

• Experience with Lean/ Six Sigma methodologies and process optimization.

Deals with all technical functions (Chemistry, Manufacturing, Engineering, Quality, R&D, and Regulatory) on a continual basis presenting technical expertise and support as needed. Works with Chemistry Manufacturing to address manufacturing problems, solutions and improvements in the manufacturing areas. Participates in cross-functional teams and may lead / support interdepartmental project team/s.

The work environment characteristics are representative of both an office and laboratory environment and may include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

Position requires ability to lift up to 20 lbs. on occasion. Up to 75% of time at lab bench or desk, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment as posted.

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $89,008.92 - $115,711.59 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

#LI-HF1