CAPA Specialist
18 hours ago
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 CAPA Specialist will support the administration and execution of the Corrective and Preventive Action (CAPA) program. This role supports compliant and effective CAPA management in alignment with ISO 13485, FDA 21 CFR 820, and internal quality system requirements. The CAPA Specialist will assist with monitoring CAPA activities, maintaining documentation, generating reports, and supporting cross‑functional teams to ensure timely and sustainable CAPA execution. This position reports to the CAPA Manager.This is an onsite position in Oxford, with flexibility, to ensure effective CAPA system support.Major ResponsibilitiesSupport administration of the CAPA process in accordance with regulatory and quality system requirementsTrack CAPA status, timelines, and deliverables to support timely closureAssist in verifying the effectiveness of CAPA actions and documentation complianceGenerate routine CAPA metrics, dashboards, and summaries for internal reviewAssist with data analysis to identify trends and opportunities for process or system improvementsSupport preparation activities for external audits and regulatory inspectionsParticipate in cross‑functional CAPA review meetings and follow‑up activitiesMaintain CAPA files, documentation, and system data integrity in the electronic QMSSupport continuous improvement efforts and ensure lessons learned are documented and sharedChampion a team‑focused, respectful approach to problem‑solving and accountabilityAdhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policiesRequirementsSkills & ExperienceDemonstrable experience in a similar role within a regulated industry (medical device, pharmaceutical, or similar) preferredExperience supporting quality systems or CAPA processes preferredExperience with MasterControl is an advantage; experience with other eQMS platforms beneficialStrong organizational skills and attention to detailEffective verbal and written communication skillsAbility to gather, organise, and interpret dataAbility to collaborate with cross‑functional partnersAnalytical mindset with interest in problem‑solving and continuous improvementQualificationsBachelor’s degree in Life Science, Engineering, or related technical discipline preferred, or equivalent experienceAbility to travel internationally occasionally (up to 10%)BenefitsAt 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.Seniority levelAssociateEmployment typeFull‑timeJob functionQuality Assurance #J-18808-Ljbffr
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