Scientist II - Field Triage (R&D)

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

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Scientist II. This individual will conduct and manage technically challenging investigations to address on-market product quality issues and recommend solutions.

Collaborating cross-functionally across QuidelOrtho, and with customers, they will use data analytics to drive scoping of investigations and decision making. They will use technical knowledge of biochemistry, physics, and process (chemical) engineering, along with scientific principles of how assays work, to design, conduct and document experiments to systematically identify failure mode/s and establish root cause/s.

This position is located in Rochester, NY.

The Responsibilities

• Assess failure modes of potential quality issues related to reagents, samples, testing protocol, consumables and analyzer systems reported by customers and internal stakeholders. Perform investigation into the product issue/s to understand nature of the problem. Work with cross-functional representatives in quality, customer support, lifecycle management team, operations and our development partners, to define the problem and deviation from intended performance.
• Perform investigation into the product issue/s to understand nature of the problem.
• Work with cross-functional representatives in quality, customer support, lifecycle management team, operations and our development partners, to define the problem and deviation from intended performance.
• Collect and analyze data from instruments and databases. Use knowledge of data analytics and statistics to discern significant trends to assess contribution of potential root causes.
• Design and conduct experiments to determine root cause either as sole investigator for small-scale and/or large investigations, or as part of a team to support large-scale investigations.
• Propose corrective actions for implementation to fix product issues.
• Document and maintain investigation records and findings.
• Communicate investigative findings to the Customer Service Organization in a way that enables broad dissemination and actionable use of technical knowledge.
• Complete Quality System records in conjunction with product investigations.
• Operate equipment in a biohazard lab environment.
• Communicate with an international community of technical support staff.
• Seek technical information and engender collaboration from development partners, inside/outside Ortho and outside the US.
• Learn the operating principles of complex electro/mechanical/software systems and scientific principles of how assay work.
• Occasional travel.
• Performs other work-related duties as assigned.

The Individual

Required:

• Minimum of 3 progressive years of experience with a Bachelor's degree in a scientific or engineering discipline. Biochemistry, Chemistry, Biology, Biotechnology or Biomedical science preferred and/or equivalent combination of education and experience.
• Ability to triage product issues and perform root cause investigations required.
• Experience with clinical chemistry and/or immunohematology systems preferred.
• Systems thinking acuity and a keen interest in diving deep into complex product issues and learning different technologies required.
• Experience in application of design of experiments to an industry setting required.
• Demonstrated ability in technical analysis and evaluation of data required.
• Ability to have a customer-oriented mindset to better anticipate needs, resolve issues more quickly and ultimately create a better user experience required.
• Ability to work well in a team environment required.
• Excellent organizational skills required.
• Excellent communication, influencing and conflict resolution skills required.
• Experience with technical writing and English fluency required.
• Ability to adapt quickly to obstacles and changing demands required.
• This position is not currently eligible for visa sponsorship.

Preferred:

• Six Sigma and/or Kepner-Tregoe background preferred.
• Background in applied statistics preferred.
• Experience with MATLAB and/or other programming/scripting languages preferred.

The Key Working Relationships

Internal Partners:

• Field Triage Team (of which this job is part), Development Team (for translating proposed solutions into actual designs), Quality (for compliance process), Operations (for deep subject matter expertise of manufacturing processes), Ortho Care (for seeking additional information, and for communicating findings).

External Partners:

• Development Partners and Suppliers (for deep investigational and raw materials assistance, and for translating proposed solutions into CAPA), Customers (for additional information related to investigations).

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.

Physical Demands

This position requires the ability to work in a biohazard lab environment and requires use of protective equipment (safety glasses, gloves, lab coats). The position requires the ability to sit, stand, walk, bend, squat, push and pull, repetitive movement (pipetting of samples). Up to 50% working in the lab, standing or sitting extended periods of time.

Salary Transparency

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 $70,000 to $80,000 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 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.