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Senior Process Engineer

3 months ago

Rochester, United States Ortho Clinical Diagnostics Full time
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

As we continue to grow as QuidelOrtho, we are seeking a Senior Process Engineer. As a Senior Process Engineer in our assay development group, you will play a critical role in the design, development, and optimization of manufacturing processes for our diagnostic products. You will work closely with a multidisciplinary team of scientists, engineers, and quality assurance professionals to ensure the quality, scalability, and capability of our diagnostic products.

At QuidelOrtho, we are dedicated to advancing healthcare through innovative diagnostic solutions. Our assay development group is a dynamic and collaborative team at the forefront of the industry. We're seeking a talented Senior Process Engineer to join us in our mission to create world class diagnostic solutions. This position is located in Rochester, NY.

The Responsibilities
  • Lead a process improvement team - ensure strategy and work plans to achieve project objectives.
  • Design and optimize manufacturing processes for diagnostic reagents and related products.
  • Implement Lean/Six Sigma principles to enhance product quality and increase manufacturing efficiency.
  • Conduct process risk assessments, failure mode analysis (FMEA), and root cause analysis to identify and resolve issues.
  • Collaborate with cross functional teams to develop and improve process specifications and quality standards.
  • Transfer the process to the manufacturing operation and verify process capability against design requirements.
  • Maintain accurate records in accordance with the QuidelOrtho Quality System.
  • Maintain core expertise in the fields of surface modification, formulation, and coating.
  • Train and mentor junior engineers and technicians, fostering a culture of continuous improvement and knowledge sharing.
  • Performs other work-related duties as assigned.
The Individual

Required:
  • Bachelor's degree in chemical engineering or related field. Master's degree in chemical engineering preferred.
  • Minimum of 5 years' experience in process engineering, particularly in the field of diagnostics, biochemistry or immunochemistry.
  • Proficiency in Lean/ Six Sigma methodologies and process optimization.
  • Experience with regulatory compliance standards (e.g., FDA, ISO).
  • Strong 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 Minitab.


The Work Environment

The work environment characteristics are representative of an office, laboratory, and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Essential functions are subject to change as other duties may be assigned.

Salary Transparency

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 that facts and circumstances of each case. Salary range for this position is $80,000 to $136,000 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.

Equal Opportunity

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 their 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.

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