Director, Field Actions and Reporting

As we continue to grow as one QuidelOrtho we are seeking a Director, Field Actions and Reporting. TheField Action and Reporting Directorisaglobal peopleleader withinQuidelOrtho' sGlobal Quality & Compliance (GQ&C) organization. This leaderis responsible fordeveloping and leading a team of Quality professionals to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enableQuidelOrtho' sRight to Operate and support business agility, innovation, and growth.This position provides strategic direction and operational oversight acrossQuidelOrtho' sField Action and Reporting activities ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The role partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization,inspectionreadiness, and continuous improvement.The role leads the strategy and execution for field action and reporting activities across the globe. The responsibilities span all quality elements associated with field actions and regulatory reporting activities andincludesthe oversight of the Safety, Recall and Regulatory Reporting processes. This role also demands identification and execution of continuous improvements toQuidelOrtho' sProduct Health and Monitoring processes at the global level to meet the current and future needs of theQuidelOrthobusiness. These improvements will ensure continued compliance with quality system regulations while driving overallefficienciesand improvements inQuidelOrtho' sProduct Health and Monitoring Processes. These initiatives will demand close collaboration with key stakeholders and business partners across the organization including but not limited to Global Service Organization, Regulatory, Operations, R&D, Site Quality, Design Quality, Global Compliance and Regulatory. This leader is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technicalexpertise, data-driven insights, and agile leadership behaviors, the Field Action and Reporting Directorensuresthat Quality System and teams deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester, NY.

• Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performanceobjectives.

• 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 ofQualityprocesses, procedures, and tools across sites and functions to strengthen compliance and efficiency.

• Partner withOperations, R&D, Regulatory Affairs,Global Service Organization,Commercialand other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.

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

• Ensure the teammaintainsa state of inspection readiness 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 leaders and technical experts 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.

• Manage departmental budget and resources effectively,identifyingopportunities to drive cost efficiencies whilemaintainingcompliance and quality standards.

• Perform other work-related duties as assigned.

Required:

• Bachelor's degree in Life Sciences, Engineering, ora relatedtechnical disciplinerequired.

• 12+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 yearsin peopleleadership.

• 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.

• Demonstratedsuccess driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.

• Excellent collaboration, influence, and communication skills across functional and organizational boundaries.

• Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.

• Experience leading in a matrixed, global organization and managing competing priorities effectively.

• Commitment to scientific integrity, compliance excellence, and continuous improvement.

Preferred:

• Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline.

• Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools.

• Experience interfacing and partnering with Regulatory Bodies or Notified Bodies in relation to Field Actionsand Regulatory Reporting activitiesincluding leading thetimelyresolution ofquestions andgeneralinquiries.

• Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise.

• Experience supporting or leading Health Authority or Notified Body inspections.

Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally.

External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers.

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment.

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:

• Thrive Together - Collaborate intentionally, grow as a team

• Make It Happen - Focus on priorities, embrace continuous improvement

• Commit to Service - Cultivate a service mindset

• Embrace Inclusion - Be open and authentic, welcome diverse perspectives

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 $179,000 to $232,000 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.

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