Manager, Data Analytics

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

QuidelOrtho is seeking a Manager, Data Analytics. The Manager, Data Analytics is a global people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals 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 Quality disciplines. operate under little to no direct supervision and provide independent guidance to the business. This position is considered a subject matter expert in Quality Data Analytics and Complaint Trending. They are accountable for the work of the Quality Data Analytics team and the success of team projects;

and will have significant amounts of critical organizational and technical knowledge. This leader is responsible for the day-to-day management and supervision of Quality Engineers and Data Analysts and is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Manager, Data Analytics ensures that Quality systems and teams deliver sustainable business and compliance outcomes.

This position will be Hybrid in any global QuidelOrtho site.

The Responsibilities

Provides independent guidance to business partners on quality data handling and analytics. Establish dashboards and data visualizations to support product quality and continuous improvement.

Leads metrics and data analytics work for Complaints, Recalls, NC, CAPA, Audits/Compliance and other areas of Quality.

Ability to manage complaint trending activities and related software system validations

Ability to compile and present quality data and analysis to the business eg: Management Review.

Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives.

Establishclear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.

Provide technical, regulatory, and operational leadership to ensure Quality systemscomply withISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.

Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency.

Promote a culture of continuous improvement byidentifyingopportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS).

Ensure the teammaintainsa state ofinspectionreadiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.

MonitorQuality performance using metrics and data analytics toidentifyrisks, drive root cause analysis, and implement sustainable improvements.

Coach and mentor emerging Quality team members to build organizational capability and ensure robust succession planning.

Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders.

Ability to identify and drive process improvements;

own process investigations, nonconformance records or corrective actions in response to audit findings.

Perform other work-related duties as assigned.

The Individual

Required:

Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required.

7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership.

Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.

Proven ability to lead and develop high-performing teams and build future technical and people leaders

Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regul