Principal GSO Quality Parnter

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 Principal GSO Quality Partner, Product Health and Monitoring. ThePrincipal GSO QualityPartnerisa globalindividual contributorwithinQuidelOrtho' sGlobal Quality & Compliance (GQ&C) organization. Thisindividualis responsible 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 role provides strategic direction and operational oversight across Quality disciplines-including Quality Systems, Compliance, Design Assurance, Quality Engineering, and Quality Control-ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). ThePrincipal GSO Quality Partner partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization,inspectionreadiness, and continuous improvement. Thisindividualis responsible forfostering a culture of engagement, collaboration, and performancewith the Global Service Organization. By integrating technicalexpertiseanddata-driven insights,thePrincipal GSO Quality Partnerensures that Quality systems deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester, NY or San Diego, CA.

• 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.

• Primarily partners with the Global Service Organization in addition toOperations, R&D, Regulatory Affairs, 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 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 Qualityteam membersto 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.

• Perform other work-related duties as assigned.

Required:

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

• 10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.

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

• 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.

• 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.

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

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

• Experience with customer complaint handling processessuch asproduct trending andcustomer communication activities.

• Experience with working across a matrix-based organization to drive collaboration and achieve results.

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.

• Temperature: Extreme heat or cold

• Noise level: Sounds or a pitch that may cause distraction

• Location: Inside or outside, such as an office or outdoors

• Weather: Wet and/or humid conditions, outside weather conditions

• Exposures: Hazardous materials, fumes, toxic chemicals, airborne particles, odors, or other unpleasant surroundings

• Workspace: Traditional workspace or remotely

• Other factors: Frequent overtime, extensive travel, emergency staff designations, or being on-call

• Sitting, standing, walking, lifting, carrying, reaching, pushing, and pulling.

• Other physical demands include bending, crawling, stooping, vision, grasping, climbing or balancing, kneeling, crouching, talking or hearing, tasting or smelling.

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 $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.

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