Senior Quality Engineer

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 THRIVE as QuidelOrtho, we are seeking a Senior Quality Engineer. The Senior Quality Engineer is focused on Quality oversight of the manufacturing of in vitro diagnostic medical devices. This position has specialized subject matter expert knowledge of raw material quality, manufacturing processes and Quality Systems and mentors/trains other personnel. The Senior Quality Engineer drives quality-related decisions, with appropriate approval authority (both data-based and risk-assessment based decisions). This position requires a large degree of independent decision making. The position will work to resolve quality issues by ensuring adequate root cause investigations conducted and verifying effectiveness of CAPAs implemented. The position will utilize key Quality Engineering principles, tools, and practices to develop and optimize raw materials, suppliers, process controls and quality system processes and identify opportunities to improve quality and cost that are aligned with the overall business goals and QuidelOrtho’ s Quality Policy. The Senior Quality Engineer will collaborate with business partners and suppliers to address quality events/nonconformances to rapidly investigate and disposition material. The individual has accountability to oversee, coordinate and execute all of the required activities for end to end for suppliers and/or the manufacturing quality processes as appropriate. This role will support/lead projects providing quality/SME guidance.  This role will author, document, and review quality record documentation. The Senior Quality Engineer will ensure audit readiness programs are effectively implemented within the organization. This includes supporting/leading through various roles such SME, technical data preparation, etc. The work should be performed to ensure compliance with company and regulatory requirements (GMP, ISO, IVDR etc.) along with QuidelOrtho core behaviors. This role develops and maintains effective working relationships with peers and business partners. The Senior Quality Engineer is a problem solver and critical thinker in all aspects of the role while navigating ambiguity and range of medium to high complexity of issues.

This position is in Pompano Beach Florida.

The Responsibilities

• Partners with Operations to evaluate and address supplier related quality events including nonconformances, product dispositions customer complaints, root cause investigations and implement appropriate corrections and/or corrective actions based on risk level.

• Analyzes and monitor key quality metrics and develop action plans to address unfavorable trends. 

• Oversees site specific supplier quality activities such as review/approval related to additions/updates to the approved supplier list, evaluation of supplier related non-conformances for Supplier CAPA eligibility, management of Supplier CAPA, evaluation of supplier chan