Senior Manager Quality Engineering Excellence

Senior Manager Quality Engineering Excellence QuidelOrtho paid time off, paid holidays, sick time, 401(k) United States, Jersey, Raritan 1001 U.S. 202 (Show on map) Apr 14, 2026 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 As we continue to grow as one QuidelOrtho we are seeking a Senior ManagerQuality Engineering Excellence. The QualityEngineering ExcellenceSenior Manager is aglobal 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.

Thepositionleads global quality engineering activities that support the manufacture,testingandrelease of in vitro diagnostic medical devices. This role is accountable for ensuring consistent, compliant, and efficient operational quality execution across global manufacturing sites.

Focusingon manufacturing quality engineering, process robustness, nonconformance management, and continuous improvement(CAPA),ensuring compliance with global regulatory requirements while supporting operational excellence and supply continuity.

This role provides strategic direction and operational oversight across Quality Engineeringensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). The Senior Manager partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization,inspectionreadiness, and continuous improvement. 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 Quality & Compliance Senior Manager ensures that Quality systems 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 with

ISO 13485, FDA 21 CFR

820, IVDR, and other applicable requirements. Drive harmonization and standardization ofOperationalQualityEngineeringprocesses, procedures, and tools across sites and functions to strengthen compliance and efficiency. Implementation of standardized NC/CAPA processes to drive robust risk management, CAPAeffectivenessand continuous improvement.

Ensure effective management of nonconformances, deviations, and rework activities using structured root cause analysis methodologies. Assess and mitigate quality risks associated with process,equipmentandmaterial.

Ensure quality engineering support for manufacturing changesandcompliant execution of change controls and validation activities.

Drivingharmonized,efficient,validationstrategies for equipment,processand facilities Partner with Manufacturing, R D, Regulatory Affairs, Supply Chain, and 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 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 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. ModelQuidelOrtho' sleadership principles bydemonstratingcollaboration, accountability, inclusion, and service mindset in all interactions. Perform other work-related duties as assigned.

The Individual Required:

Bachelor's degree in Life Sciences, Engineering, ora relatedtechnical disciplinerequired. 8+ 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. Willingness and ability to travel approximately 10-15%.

Preferred:

Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. Experience implementing oroptimizingglobal Quality Management Systems (QMS) and digital tools. Lean Six Sigma, PMP, or similar certificationdemonstratingprocess improvementexpertise. 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. Standard activities include sitting, standing, walking, talking, hearing, and visual work. 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 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 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 $155,000 to $202,000 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 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 recruiting@quidelortho.com. #LI-SP1