Quality Partner, Technical Quality Investigation

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 Staff Quality Partner, Technical Quality Investigation. The Staff Quality Engineer leads complex, long term, product focused quality investigations for in vitro diagnostics, owning issues that affect form, fit, function, or on market performance from problem statement through verified, sustainable corrective and preventive actions. This role designs and executes rigorous investigative plans, applies advanced root-cause analysis and risk management, and leverages deep product and process knowledge to drive data driven decisions.

The engineer interfaces with SQIR/PQR processes to support recall and field action recommendations, communicates investigation status, risks, and remediation plans to cross functional stakeholders and leadership, and partners closely with R&D, Manufacturing, Regulatory, and Post Market Surveillance. As an auditee, the role provides comprehensive global audit support and evidence of compliance. Success requires exceptional analytical and problem solving skills, critical thinking, and strong cross functional collaboration to ensure patient safety, product reliability, and compliance with applicable IVD quality system regulations and standards.

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 Staff Quality Partner partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement.

This individual is responsible for fostering a culture of engagement, collaboration, and performance. By integrating technical expertise and data-driven insights, the Staff Quality Partner ensures that Quality systems deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester, NY.

• Lead long term, product focused quality investigations for on market IVD products. term, product focused quality investigations for on market IVD products.term, product focused quality investigations for onmarket IVD products.

• Own and execute investigations impacting product form, fit, function, and performance.

• Design, plan, and conduct rigorous investigative studies using structured root cause methodologies. cause methodologies.cause methodologies.

• Apply risk management principles to assess patient, product, and business impact and guide decision making. management principles to assess patient, product, and business impact and guide decision making.management principles to assess patient, product, and business impact and guide decision making.

• Interface with SQIR/PQR processes to inform recall and field action recommendations.

• Develop, present, and communicate investigation updates, findings, and corrective actions to cross functional stakeholders and leadership. functional stakeholders and leadership.functional stakeholders and leadership.

• Collaborate with R&D, Manufacturing, Regulatory, Post Market Surveillance, and other partners to drive effective problem resolution.
  
  Market Surveillance, and other partners to drive effective problem…