Product Quality Engineer

ABOUT ORGANOX:
Organ Ox is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. Organ Ox is a pioneer in normothermic machine perfusion (NMP). It s flagship platform, the metra, is available for use in the U.S., Europe, Canada, and Australia.

It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

ABOUT ORGANOX:
Organ Ox is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. Organ Ox is a pioneer in normothermic machine perfusion (NMP). It s flagship platform, the metra, is available for use in the U.S., Europe, Canada, and Australia.

It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary

The Product Quality Engineering team at Organ Ox is a technical quality engineering team responsible for monitoring, understanding, and improving product performance of the Organ Ox Metra, a Class III medical device. The Product Quality Engineering team works closely with Product Sustaining Engineering and Contracted Suppliers to set in place quality control and management processes for externally built products and componentry, including sterilization and microbiology, supplier management, and contract manufacturing processes.

The Product Quality Engineer will have strong technical skills with an ability to analyze product quality issues and work cross-functionally to solve problems related to product quality.

This is a flexible, on-site role in Oxford, UK.

Major Responsibilities

• Under direction from the Senior Product Quality Engineer and Senior Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for the following:
• Analyze and trend on product performance data to provide recommendations for product improvements
• Investigation and disposition of nonconforming material through Non-Conforming Material (NCMR) and Supplier Corrective Action Reports (SCARs) processes in response to product performance trends
• Support root cause investigation and timely closure of SCARs
• Work cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failures.
• Maintain good working relationships with suppliers to support root cause investigation and failure mitigation efforts
• Supports updates to supplier quality agreements
• Support hands-on analyses of returned products to identify root causes of failures
• Support development of investigation criteria and test methods to properly diagnose and root cause field failures
• Provide technical insight to sterilization and microbiological processes
• Support CAPAs, Escalations, and engineering investigations in response to field quality issues.
• Participate in the development and review of engineering change orders that impact product quality activities
• Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations
• Adhere to the letter and spirit of Organ Ox s Code of Conduct and all other company policies

Requirements

Skills & Experience

• Demonstrable related hands on engineering experience in the medical device industry, or equivalent
• Knowledge of electro-mechanical troubleshooting techniques
• Familiarity with ISO
  14971 and associated Risk Management Processes is a plus
• Knowledge of medical device sterilization and microbiology preferred
• Excellent technical report writing skills
• Strong Root Cause Analysis, Design Of Experiments, and test method development experience as related to complaint investigations
• Experience investigating and resolving SCARS and CAPAs
• A solid understanding of the FDA QSR Quality…