Principal GSO Quality Parnter

The Opportunity

Quidel Ortho 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 Quidel Ortho we are seeking a Principal GSO Quality Partner, Product Health and Monitoring. The Principal GSO Quality Partnerisa global individual contributor within

Quidel

Ortho' sGlobal Quality & Compatibility (GQ&C) organization. Thisindividualis responsible to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable

Quidel

Ortho' 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). The Principal GSO Quality Partner partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement. Thisindividualis responsible for fostering a culture of engagement, collaboration, and performance with the Global Service Organization.

By integrating technicalexpertiseanddata-driven insights,the Principal GSO Quality Partner ensures that Quality systems deliver sustainable business and compliance outcomes.

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

• Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.

• Provide technical, regulatory, and operational leadership to ensure Quality systems comply with
  
  ISO 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 to Operations, R&D, Regulatory Affairs, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.

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

• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.

• Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.

• Coach and mentor emerging Quality team 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, or related technical discipline required.

• 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.

• Demonstrated success 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 processes such as product trending and customer communication activities.

• Experience with working across a matrix-based organization to drive collaboration…