Product Quality Engineer

OrganOx LimitedMadison, New Jersey, United States

On-site Full-time

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Key Responsibilities:Conduct detailed analyses of returned products to ascertain root causes of failures. Establish investigation criteria and testing methodologies for accurate diagnosis of field failures. Analyze product performance data to identify trends and provide actionable recommendations for enhancements. Perform quality trending of service data and investigate to uncover causes behind service-related complaints, including workmanship issues and out-of-box failures. Review service output and related complaint or non-conformance investigation results to ensure compliance with all regulatory and service requirements, aligning with facility, divisional, and corporate objectives for defect prevention and continuous improvement. Audit and assess complaint investigations and records to ensure high-quality outcomes.

About the job

ABOUT ORGANOX:

OrganOx is a cutting-edge commercial stage organ technology firm committed to advancing innovative technologies aimed at enhancing outcomes for patients suffering from acute or chronic organ failure. Established in 2008 as a spin-out from the University of Oxford, OrganOx is now part of the esteemed Terumo Group. As a trailblazer in normothermic machine perfusion (NMP), our flagship platform, the metra®, is operational in the U. S., Europe, Canada, and Australia. This technology has been pivotal in over 7,000 liver transplants, ensuring donor livers remain metabolically active outside the body. This innovation allows for extended preservation times and functional assessments of organs prior to transplant, significantly increasing the availability of transplantable organs. Founded in 1921, Terumo Corporation (TSE:4543) aims to fulfill its mission of “Contributing to Society through Healthcare” by offering a wide array of solutions in therapeutic procedures, hospital operations, and life sciences across more than 160 countries and regions.

Position Summary

The Product Quality Team at OrganOx is a specialized technical engineering team dedicated to monitoring, understanding, and enhancing product performance, along with managing quality processes within the service organization.

The ideal Product Quality Engineer will be hands-on, technically adept, and focused on customer satisfaction while possessing the analytical skills necessary to identify, diagnose, and resolve product quality issues. Successful candidates will demonstrate accountability, collaboration, excellent communication, and problem-solving skills, along with a passion for delivering world-class healthcare solutions that are accessible, simplified, and safe.

Below are the primary responsibilities associated with this role, along with a brief overview of key tasks. This list is not exhaustive.

This position requires on-site presence at our Madison, NJ facility.

About OrganOx Limited

OrganOx is an innovative leader in organ preservation technology, inspiring change in the field of organ transplantation. With a commitment to improving patient outcomes, we leverage advanced scientific research and engineering excellence, creating solutions that enhance the quality of healthcare worldwide.

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Full-time|On-site|Wisconsin - Madison

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