{"id":20717,"url":"https://alion.io/job/organox-software-quality-engineer","title":"Software Quality Engineer","company":{"id":5872,"name":"OrganOx","domain":"organox.com","url":"https://alion.io/company/organox","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"QA","role_family":"QA","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Oxford, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"EU MDR","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-02T17:16:43Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-07T06:21:07Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":4},"description":"ABOUT ORGANOX:\nOrganOx 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. OrganOx 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.\nPosition Summary\nThe Software Quality Engineer will work closely with R&D, Engineering, Post-Market Operations and Quality teams to ensure effective control of design, development, risk assessment, and change control.\nThey will provide Quality and Design Assurance oversight across the software lifecycle for medical devices, including IEC 62304 software and digital health applications. The role works closely with Regulatory Affairs to ensure software documentation and procedures meet applicable standards and regulatory expectations\nBuilding upon the company’s success in organ preservation for liver transplantation, several new applications of the technology are now being actively developed. The successful candidate will join a rapidly growing Quality department working with R&D, Post-Market Engineering, Cybersecurity and Regulatory Affairs and play a key role in supporting compliance with EU MDR, FDA requirements and applicable software and cybersecurity standards, for new and existing products.\nA central responsibility of the role is ensuring effective software risk management, particularly the development and maintenance of Software FMEAs (SFMEAs), software hazard analyses, cybersecurity risk assessments and associated risk controls\nThis is an onsite role in Oxford with flexibility.\nMajor Responsibilities\nUnder direction from the Software Quality Manager, the Software Quality Engineer will:\nAssure software quality throughout the full lifecycle process in accordance with OrganOx software standards and procedures for software up to safety class C per IEC 62304. \nEnsure effective implementation of software design controls, including requirements, architecture, verification and validation, configuration management, change control and release management. \nEnsure appropriate traceability between software hazards, failure modes, software requirements, risk-control measures and verification evidence. \nEnsure software FMEAs are aligned with system-level risk analyses, including system FMEAs, use-related risk analyses and the overall ISO 14971 risk-management file. \nReview software lifecycle documentation for completeness, consistency, traceability and regulatory compliance. \nParticipate in design reviews, risk reviews, change assessments, project milestones and release-readiness reviews. \nProvide Quality oversight of cybersecurity risk management, including threat modelling, vulnerability assessment, SOUP and third-party software. \nMaintain and improve software procedures in line with IEC 62304, ISO 13485, ISO 14971, EU MDR, applicable FDA requirements and cybersecurity guidance. \nSupporting Quality oversight of computer system validation/assurance (CSV)/CSA. \nEnsure software defects, complaints, post-market information and cybersecurity vulnerabilities are assessed for their impact on the SFMEA and wider risk-management file. \nSupport software-related nonconformances, CAPAs, complaints, audits and regulatory inspections. \nContribute as part of the team to assist in other tasks as necessary. \nAdhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies\nRequirements\nSkills & Experience\nExperience as a software quality engineer, or in a similar quality role, within the medical device industry, supporting SaMD, digital health applications or software in a medical device. \nExperience developing, facilitating and reviewing SFMEAs and software hazard analyses for medical-device software under ISO 14971. \nExperience reviewing software requirements, architecture, traceability, verification evidence, changes and release documentation. \nExperience working in cybersecurity risk assessment (Desirable). \nExperience in supporting, conducting, and reviewing activities and processes related to computer system validation (CSV). \nExperience with GAMP5 classification used for CSV (Desirable). \nPractical working knowledge of IEC 62304, ISO 14971, ISO 13485, EU MDR and applicable FDA software requirements and guidance. \nStrong analytical and communication skills, with the ability to facilitate cross-functional risk discussions and constructively challenge technical decisions. \nExperience working within a quality management system and following standard operating procedures. \nExperience working in Quality within the medical device industry (Desirable). \nExperience with SOUP, nonconformances, CAPA, complaints and regulatory audits (Desirable). \nKnowledge of IEC 81001-5-1, IEC 82304-1 and FDA cybersecurity guidance (Desirable).\nQualifications\nA degree or equivalent experience in software engineering, computer science, information engineering, systems engineering, quality engineering or a related discipline. \nBenefits\nAt 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.\nWe 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.","description_format":"text","description_chars":6353,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development","Retirement plans"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Information Security","Biomedical Engineering"],"lifecycle":[{"event":"open","at":"2026-06-04T00:00:00Z"},{"event":"close","at":"2026-07-28T22:50:09Z"},{"event":"reopen","at":"2026-11-02T13:10:35Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"Licensed UK visa sponsor (Senior or Specialist Worker, Skilled Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Global Business Mobility: Senior or Specialist Worker; Skilled Worker","cap_exempt":false,"checked_at":"2026-11-07T07:57:00+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":4,"expected_fill_days":39,"reasons":["conf:3","velocity","win:early"],"computed_at":"2026-11-07T05:47:08Z"},"pay":null,"html_url":"https://alion.io/job/organox-software-quality-engineer","json_url":"https://alion.io/job/organox-software-quality-engineer.json","meta":{"generated_at":"2026-11-07T09:31:29Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":7524,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-08T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5872},"rest":"https://alion.io/mcp/rest/get_company?id=5872"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Forganox-software-quality-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Forganox-software-quality-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Forganox-software-quality-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/organox-software-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Forganox-software-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":20717}},{"tool":"search_jobs","arguments":{"company":"organox.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":20717},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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