OverviewProduct Quality Engineer - Disposable Set at OrganOx. OrganOx is a global medical device company focused on improving transplantation outcomes. 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 Engineering team monitors, understands, and improves product performance of the OrganOx Metra (Class III medical device). The team collaborates with Product Sustaining Engineering and contracted suppliers to establish quality control and management processes for externally built products and components, including sterilization, microbiology, supplier management, and contract manufacturing processes. The Product Quality Engineer will analyze product quality issues, work cross-functionally to solve problems, and contribute to delivering world-class, safe, accessible healthcare.Major ResponsibilitiesAnalyze and trend product performance data to provide recommendations for product improvementsRaise Supplier Corrective Action Reports (SCARs) and Nonconforming Material Reports (NCs) in response to product performance trendsSupport root cause investigation and timely closure of SCARs and NCsWork cross-functionally with other engineering teams and contracted suppliers to implement changes in manufacturing and inspection procedures to mitigate field failuresMaintain good working relationships with suppliers to support root cause investigation and failure mitigation effortsSupport updates to supplier quality agreementsSupport validation of new processes at suppliersSupport hands-on analyses of returned products to identify root causes of failuresSupport development of investigation criteria and test methods to properly diagnose and root cause field failuresProvide technical insight to sterilization and microbiological processesSupport CAPAs, escalations, and engineering investigations in response to product quality issuesParticipate in the development and review of engineering change orders that impact product quality activitiesPerform DHR, Service History records, and PFMEA reviews in support of complaint investigationsAdhere to OrganOx's Code of Conduct and company policiesRequirements & SkillsDemonstrable hands-on engineering experience in the medical device industry, or equivalentKnowledge of medical device sterilization and microbiology is preferredExcellent technical report writing skillsStrong Root Cause Analysis, Design Of Experiments, and test method development experience related to complaint investigationsExperience investigating and resolving SCARs and CAPAsUnderstanding of FDA QSR Quality System Requirements; ability to apply this knowledge to meet goalsStrong experience with MS Office; proficiency in statistical analysis (Minitab preferred); Six Sigma knowledge is a plusExcellent oral and written communication skills across audiences of varying technical levelsAbility to prepare written technical plans and reports in support of engineering changes, product/process validations, and failure investigationsCustomer-focused mindset and ability to work across global teamsSelf-driven, capable of solving complex problems, and upholding OrganOx valuesExperience driving a global quality mindset across teams and geographiesDemonstrated attention to detail and "do it right the first time" attitudeQualificationsBachelor's degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or equivalent work experienceAbility to travel 10-20%Familiarity with ISO 14971 and Risk Management is a plusSix Sigma Green Belt or Black Belt Certification preferredBenefitsOrganOx offers competitive compensation and comprehensive benefits, including healthcare and retirement plans. We value innovation, evidence, integrity, teamwork, respect, and passion, supporting work-life balance and ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender identity, pregnancy, race, religion or belief, sex, sexual orientation, or any other characteristics protected by law. #J-18808-Ljbffr