Quality Lead, Requirements and Specifications Management (Assay)
QuidelOrtho, Rochester, NY, Onsite
Quality Assurance ControlBachelor RequiredSenior
QuidelOrtho, Rochester, NY, Onsite
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.
As we continue to grow as one QuidelOrtho we are seeking a Quality Lead, Requirements and Specifications Management (Assay). The Quality Lead, Requirements and Specifications Management (Assay) is a global individual contributor within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This individual is responsible to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role provides strategic direction and operational oversight across product lifecycle quality with responsibility for defining, owning, and continuously improving the end to end requirements and specifications framework for a portfolio of assay based medical device products. This role establishes standardized processes, templates, and best practices that ensure product, system, and manufacturing requirements are clear, traceable, compliant, and fit for purpose across the entire product lifecycle. The Quality Lead works cross-functionally to embed Quality and Compliance principles throughout the product lifecycle.
This individual acts as the subject matter authority for requirements and specifications—partnering closely with R&D, Systems Engineering, Design Quality, Regulatory Affairs, Manufacturing, and Product Management to ensure robust design inputs that enable compliant, scalable, and high quality product development. This role is responsible for the governance, definition, and continuous improvement of the organization’s assay requirements and specifications of management processes. This role functions as the enterprise subject matter expert and process owner, leading through influence, expertise, and accountability rather than people management.‑to‑end requirements and specifications framework for a portfolio of assay‑based medical device products. This role establishes standardized processes, templates, and best practices that ensure product, system, and manufacturing requirements are clear, traceable, compliant, and fit for purpose across the entire product lifecycle.
The Quality Lead works cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving This individual acts as the subject‑matter authority for requirements and specifications—partnering closely with R&D, Systems Engineering, Design Quality, Regulatory Affairs, Manufacturing, and Product Management to ensure robust design inputs that enable compliant, scalable, and ‑quality product development. This role is responsible for the governance, definition, and continuous improvement of the organization’s assay requirements‑matter expert and process owner, leading through influence, expertise, and accountability rather than people management. This individual is responsible for fostering a culture of engagement, collaboration, and performance. By integrating technical expertise and data-driven insights, the Quality Lead ensures that Quality systems deliver sustainable business and compliance outcomes.
This position will be onsite in Rochester, NY.
Typical office or laboratory environment. May involve virtual collaboration across multiple global sites.
No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support.
At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they’re essential to how we thrive as a team and achieve meaningful impact:
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 $135,000 to $175,000 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.
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