{"id":1660882,"url":"https://alion.io/job/marmon-sr-software-quality-assurance-engineer","title":"Sr. Software Quality Assurance Engineer","company":{"id":5432,"name":"Marmon Holdings","domain":"marmon.com","url":"https://alion.io/company/marmon","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":98,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":13,"computed_at":"2026-10-17T05:46:00Z"}},"role":"QA","role_family":"QA","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Charlottesville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":88000,"max":110000,"currency":"USD","period":"year","gross":null,"usd_annual":110000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Azure DevOps","optional":false},{"name":"C++","optional":false},{"name":"CI/CD","optional":false},{"name":"GitHub","optional":false},{"name":"GitLab","optional":false},{"name":"Jira","optional":false},{"name":"Azure","optional":true}],"status":"live","first_seen_at":"2026-09-24T00:00:00Z","employer_posted_date":"2026-09-24","last_verified_at":"2026-10-17T22:19:47Z","board_verified":true,"closed_at":null,"days_open":24,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":24},"description":"MicroAire Surgical Instruments LLCAs a part of the global industrial organization Marmon Holdings-which is backed by Berkshire Hathaway-you’llbe doing things that matter, leading at every level, and winning a better way. We’recommitted to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’sempowered to be their best.\nThe Senior Software Quality Assurance Engineer provides independent Quality oversight and advanced technical guidance for the development, validation, release, and post-market maintenance of software-based medical devices throughout the product lifecycle. This role independently leads complex software Quality activities within established quality system and software lifecycle frameworks such as reviewing software requirements, testing strategies, cybersecurity controls and validation; while supporting continuous improvement.This role partners closely with Software Development, Product Development, Regulatory Affairs, Manufacturing, and Product Management to ensure products are safe, effective, secure, and compliant with applicable regulatory and Quality requirements.\nLove finding the question no one has asked yet? At MicroAire, software quality is about more than checking a box. It helps ensure the medical devices clinicians rely on are safe, effective, and secure.\nWe’re looking for a Senior Software Quality Assurance Engineer who can dig into complex software, spot risks early, and work with engineers to find practical solutions. You’ll lead software quality activities across development, testing, release, and ongoing product support, partnering with teams across Engineering, Regulatory, Product, and Manufacturing.\nIf you enjoy connecting the technical details to the people who depend on the product, bring your curiosity and sound judgment to a team where your work matters.\n+ Essential Duties and Responsibilities\nSOFTWARE QUALITY AND DESIGN CONTROL OVERSIGHT\nProvide Quality Assurance oversight for software development activities throughout the product lifecycle.\nEnsure compliance with Design Control and Software Lifecycle requirements.\nAuthor, review, and approve software development documentation within delegated authority and in accordance with established procedures, including:User Needs\nDesign Inputs and Requirements\nSoftware Design Specifications\nVerification and Validation Protocols\nTest Reports\nTraceability Matrices\nRelease Documentation\nRisk Management Documentation\n\nParticipate in design reviews, software development reviews, risk reviews, and release reviews.\nEnsure software development processes comply with internal Quality Management System (QMS) requirements.\nTECHNICAL SOFTWARE REVIEW\nReview software technical documentation and development practices for compliance with Quality and regulatory requirements.\nParticipate in technical evaluation of source-code or code-review evidence, as applicable.\nEvaluate software design and technical risk assessments.\nAssess software change requests and their impact on product Quality, risk, and regulatory compliance.\nSupport investigations of software defects and field issues through technical review and root cause analysis.\nCollaborate with engineering teams to drive continuous improvement in software Quality and development practices.\nVERIFICATION AND VALIDATION\nLeads the development and execution of product or project level software verification and validation strategies within established lifecyle and Quality frameworks.\nEnsure testing is performed, documented, and reviewed at appropriate levels, including:Unit Testing\nIntegration Testing\nSystem Testing\nRegression Testing\nAutomated Testing\nUser Acceptance Testing\n\nVerify traceability between requirements, risks, design outputs, and testing activities.\nEvaluate test coverage, unresolved defects, and release readiness.\nRISK MANAGEMENT\nSupport software risk management activities in accordance with applicable standards and regulations.\nParticipate in:Hazard Analyses\nFailure Modes and Effects Analyses (FMEA)\nCybersecurity Risk Assessments\nBenefit-Risk Evaluations\n\nEnsure software-related risks are identified, controlled, verified, and documented.\nCYBERSECURITY QUALITY OVERSIGHT\nProvide Quality oversight for secure software development lifecycle activities.\nReview cybersecurity documentation, including:Threat Models\nSecurity Requirements\nVulnerability Assessments\nPenetration Testing Reports\nSecurity Risk Assessments\nSoftware Bills of Materials (SBOMs)\n\nSupport implementation and maintenance of cybersecurity processes consistent with IEC 81001-5-1.\nCollaborate with Cybersecurity and IT teams to ensure alignment with organizational information security controls and ISO/IEC 27001 principles.\nSupport post-market cybersecurity monitoring, vulnerability management, and security update processes.\nQUALITY SYSTEM AND COMPLIANCE\nEnsure compliance with applicable global regulatory and Quality requirements.\nSupport internal audits, supplier audits, notified body audits, MDSAP audits, and regulatory inspections.\nReview software-related nonconformances, deviations, CAPAs, and complaint investigations.\nSupport Management Review activities and software Quality metric reporting.\nLead and implement continuous improvement initiatives within the software Quality system.\nSUPPLIER QUALITY AND THIRD-PARTY SOFTWARE OVERSIGHT\nSupport qualification and oversight of software suppliers and development partners.\nReview supplier Quality documentation and audit results.\nAssess risks associated with third-party software components, open-source software, and cloud service providers.\nSupport supplier corrective action activities as required.\n+ Education and Experience\nBachelor's degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, Computer Engineering, or a related technical discipline.\nMinimum of five (5) years of progressive experience in Software Quality Assurance, Software Engineering, Software Validation, or Software Quality Engineering within a regulated industry, including demonstrated experience independently leading complex software Quality activities in a regulated environment.\nHands-on software development experience with the ability to independently evaluate software engineering deliverables.\nExperience with one or more programming languages, including C++, and embedded software development.\nAbility to assess software development best practices.\nUnderstanding of software build and release processes.\nKnowledge of APIs, cloud services, and system integrations.\nExperience with Azure DevOps, GitHub, GitLab, Jira, Jama, Automated testing frameworks and Continuous Integration/Continuous Deployment (CI/CD) Environments\nWorking knowledge of:\nFDA 21 CFR Part 820\nFDA Design Controls\nFDA Software Validation Guidance\nFDA Cybersecurity Guidance\nISO 13485\nISO 14971\nIEC 62304\nIEC 60601\nIEC 81001-5-1\nISO/IEC 27001\nEU MDR\nMDSAP Requirements\nApplicable global medical device regulations and standards\n\nPreferred Qualifications\nMedical device industry experience.\nExperience with Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), embedded software, connected medical devices, mobile applications, cloud-based software platforms, and/or AI-enabled technologies.\nAbility to read and understand source code. Experience participating in code reviews.\nUnderstanding of software architecture and design patterns.\nExperience participating in regulatory inspections and Quality system audits.\nASQ Certified Software Quality Engineer (CSQE)\nISTQB Software Testing Certification\nCertified Secure Software Lifecycle Professional (CSSLP)\nCertified Information Systems Security Professional (CISSP)\nISO/IEC 27001 Internal Auditor or Lead Auditor\n+ Competencies\nCompetency\nSkills\nBehaviors\nAdvanced Software Quality Expertise\nSoftware Quality systems\nDesign controls\nCompliance oversight\nRisk-based decision making\nProvides independent, objective Quality oversight for complex software activities.\nApplies established Quality frameworks with sound judgment.\nCoaches colleagues and leads cross-functional technical reviews.\nEscalates systemic, novel, or significant risks appropriately.\nTechnical Expertise\nSoftware development\nCode review, as needed\nArchitecture evaluation, as needed\nValidation methodologies\nApplies technical expertise to assess software Quality and engineering deliverables\nRisk Management\nSoftware risk assessment\nFMEA\nCybersecurity risk evaluation\nMakes sound, risk-based decisions\nProactively identifies potential issues\nCommunication & Influence\nTechnical writing\nPresentation\nStakeholder engagement\nBuilds strong cross-functional relationships\nInfluences without direct authority\nAnalytical Thinking\nRoot cause analysis\nProblem solving\nData evaluation\nInvestigates issues thoroughly\nDevelops practical solutions\nContinuous Improvement\nProcess improvement\nAudit readiness\nQuality metrics\nDrives enhancements to systems, processes, and organizational performance\n+ Work Environment, Physical Demands and Protective Equipment\n· This is a senior individual-contributor role. The position may provide technical guidance, mentoring, and work direction but does not have direct supervisory responsibility unless separately assigned.\nPrimarily office-based environment with regular collaboration across Quality, Engineering, Regulatory Affairs, and Product Management functions.\nRequires extensive computer and software system use.\nMay involve participation in audits, inspections, manufacturing observations, design reviews, and supplier assessments.\nMust be able to review technical documentation and quality records for extended periods.\nRequires adherence to company quality, information security, and confidentiality requirements.\nFollows protective equipment procedures for each department. \n+ Schedule, Travel Responsibility, Special Conditions or Requirements\n· Optimal Work Schedule: 8:00am - 5:00pm\nSchedule can be flexible within the range of 6:30am-6:00pm.\n· Must be able to work effectively in a fast-paced, highly regulated environment.\n· Occasional travel may be required to support audits, supplier evaluations, business meetings, training, or regulatory activities.\n· May participate in critical product support, compliance, or investigation activities as business needs require.\n· Must maintain compliance with applicable quality system, cybersecurity, and regulatory requirements.\nPay Range: $88,000 to $110,000\nFollowing receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processesas permitted or required by applicable law.\nWe are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.","description_format":"text","description_chars":11086,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Plastics & Polymers","Power Grid","Information Security"],"lifecycle":[{"event":"open","at":"2026-10-02T03:39:45Z"}],"visa":[],"liveness":{"score":18,"band":"cold","label":"Long shot","p_open":1,"p_active":0.409,"p_room":0.45,"age_days":23,"expected_fill_days":13,"reasons":["conf:0","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-10-17T05:46:00Z"},"pay":{"stated_usd_annual":110000,"is_top_pay":false},"html_url":"https://alion.io/job/marmon-sr-software-quality-assurance-engineer","json_url":"https://alion.io/job/marmon-sr-software-quality-assurance-engineer.json","meta":{"generated_at":"2026-10-18T02:23:13Z","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":3870,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-19T00:00:00Z"}},"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":5432},"rest":"https://alion.io/mcp/rest/get_company?id=5432"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmarmon-sr-software-quality-assurance-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%2Fmarmon-sr-software-quality-assurance-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%2Fmarmon-sr-software-quality-assurance-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/marmon-sr-software-quality-assurance-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmarmon-sr-software-quality-assurance-engineer"}]}