ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

POSITION SUMMARY

The Product Quality Engineer oversees device inspection and acceptance activities for the OrganOx Metra, a Class III medical device. These activities include but are not limited to oversight of incoming inspection, nonconforming material and material review board, calibration and measurement systems, and product acceptance. This position works closely with contracted manufacturers and quality inspectors to ensure day to day execution of these critical business processes and lead improvements of these processes.
This position involves supervisory responsibilities of Quality Inspectors and technicians, as well as executing continuous improvement initiatives to improve product quality. This is an onsite position.
Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

SKILLS & EXPERIENCE

• 2-5 years of related quality engineering work experience within the medical device field or other highly regulated industry required
• Knowledge of regulatory and quality standards: FDA QSR, ISO 13485, ISO 14971, EU MDR.
• Ability to travel internationally up to 30% to support contract manufacturers and suppliers, visit OrganOx sites, and visit customer sites
• Demonstrable technical quality engineering skills including root cause analysis, test method development, fixture development, and project management
• Experience working with nonconformances, CAPAs and SCARs
• Proven track record of problem solving and improving quality processes
• Experience with statistics and data analysis

QUALIFICATIONS

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field required
• ASQ Certifications (CQE, CMQ/OE, CQA) preferred
• Six Sigma Green Belt or Black Belt Certification preferred

Under direction from the Sr. Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for:

• Leadership and Team Development

• • Day to day management of quality inspectors and technicians
• Define team goals in collaboration with the Sr. Manager, Product Quality Engineering
• Manage performance reviews and development plans for quality inspectors and technicians
• Day to Day management and monitoring of KPIs related to product quality (Ex- Investigation Aging, NC aging and resolution)
• Promote a culture of accountability, collaboration and continuous improvement.
• Technical Quality Engineering Oversight
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• Conducting hands on oversite of the device acceptance process, ensuring device acceptance targets are met.

• Conducting hands on oversight of the incoming inspection process, ensuring inspection targets are met.
• Conduct root cause investigations regarding non-conforming product
• Lead and support continuous process improvements related to device acceptance and incoming inspection
• Leading Material Review Board and dispositioning inspected product
• Execution of non-conformances
• Trending and analysis of non-conformance data to drive decisions
• Support updates to specification templates and inspection criteria
• Support development of inspection fixtures and tooling
• Ensure calibration records are up to date
• Lead and support quality process improvements, identify systemic issues and drive continuous improvement initiatives
• Regulatory Compliance & QMS
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• Ensure adherence to regulatory standards: FDA 21 CFR 820, ISO 13485, EU MDR, MDSAP, etc.

• Support regulatory submissions, internal audits, and external inspections (e.g., FDA, Notified Body).
• Maintain and improve quality processes and documentation within the QMS.
• Cross-Functional Collaboration
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• Participate in Design Reviews and Change Control Boards.

• Collaborate with suppliers and contract manufacturers on quality standards, audits, and issue resolution.
• Communicate diligently with evidence-based communication to management and peers
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies