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 SummaryThe 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.Major ResponsibilitiesUnder direction from the Sr. Manager, Product Quality Engineering, the Product Quality Engineer may be responsible for:Leadership and Team DevelopmentDay to day management of quality inspectors and techniciansDefine team goals in collaboration with the Sr. Manager, Product Quality EngineeringManage performance reviews and development plans for quality inspectors and techniciansDay 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 OversightConducting 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 productLead and support continuous process improvements related to device acceptance and incoming inspectionLeading Material Review Board and dispositioning inspected productExecution of non-conformancesTrending and analysis of non-conformance data to drive decisionsSupport updates to specification templates and inspection criteriaSupport development of inspection fixtures and toolingEnsure calibration records are up to dateLead and support quality process improvements, identify systemic issues and drive continuous improvement initiativesRegulatory Compliance & QMSEnsure 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 CollaborationParticipate 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 peersAdhere to the letter and spirit of OrganOx's Code of Conduct and all other company policiesRequirementsSkills & Experience2-5 years of related quality engineering work experience within the medical device field or other highly regulated industry requiredKnowledge 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 sitesDemonstrable technical quality engineering skills including root cause analysis, test method development, fixture development, and project managementExperience working with nonconformances, CAPAs and SCARsProven track record of problem solving and improving quality processesExperience with statistics and data analysisQualificationsBachelor's degree in Engineering, Life Sciences, or a related technical field requiredASQ Certifications (CQE, CMQ/OE, CQA) preferredSix Sigma Green Belt or Black Belt Certification preferredBenefitsAt OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law. #J-18808-Ljbffr