Director, Field Actions and Reporting

The Role

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 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 harmonizationinspectionreadiness and continuous 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.

The Responsibilities

• 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 AffairsGlobal Service OrganizationCommercialand 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 effectivelyidentifyingopportunities to drive cost efficiencies whilemaintainingcompliance and quality standards.

• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelors 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.

Key Interactions

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.

Work Environment

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

The Physical Demands

No strenuous physical activity required. May include occasional travel for site visits leadership meetings or regulatory support.

How We Work

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 theyre 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 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 $179000 to $232000 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 Employment 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 .

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