{"id":3897287,"url":"https://alion.io/job/abbott-senior-software-quality-engineer","title":"Senior Software Quality Engineer","company":{"id":2710,"name":"Abbott","domain":"abbott.com","url":"https://alion.io/company/abbott","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":298,"ghost_share":0.003,"stale_share":0.742,"repost_share":0.02,"time_to_fill_p50_days":29,"computed_at":"2026-11-07T05:47:08Z"}},"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":["Sylmar, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":90000,"max":180000,"currency":"USD","period":"year","gross":null,"usd_annual":180000},"salary_estimate":null,"experience_years_min":7,"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":"2026-11-04T00:00:00Z","employer_posted_date":"2026-11-04","last_verified_at":"2026-11-07T14:52:25Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:\nWorking at Abbott\nAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:\nCareer development with an international company where you can grow the career you dream of.\nEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.\nAn excellent retirement savings plan with high employer contribution\nTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.\nA company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.\nA company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.\nMAIN PURPOSE OF THE ROLE\nThis is an ONSITE role based out of Sylmar, CA\nThis position is responsible for software quality, compliance, and design assurance activities associated with cloud-based medical device applications and supporting infrastructure. This role ensures software systems are developed, verified, validated, and maintained in compliance with applicable medical device regulations, quality system requirements, cybersecurity standards, and design control processes.\nThe position works closely with Development, Systems, DevOps, Product Management, Clinical Affairs, Cybersecurity, and Regulatory Affairs team to deliver secure, reliable, and compliant software solutions that support patient care and business objectives.\nMAIN RESPONSIBILITIES\nSupport all phases of the Software Development Lifecycle (SDLC), including requirements development, architecture, implementation, verification, validation, release management, post-market support, and continuous improvement.\nReview software lifecycle deliverables, participate in design and release reviews, and ensure software development activities align with Design Control requirements, software lifecycle standards, and risk management processes throughout the product lifecycle.\nParticipate in change impact assessments by evaluating the impact of software changes on product requirements, risk controls, testing, system performance, and regulatory compliance.\nAssist in the completion and maintenance of risk management files, focused on software and system related risks.\nLead quality and compliance assessments for software defects and product issues, ensuring appropriate risk evaluations, impact assessments, and escalation processes are executed to support timely customer communications, regulatory reporting evaluations, and corrective action activities\nEvaluate verification and validation strategies, test coverage, traceability, and defect management activities to ensure requirements, risk controls, cybersecurity considerations, and intended use are adequately addressed and supported by objective evidence for compliant product releases\nSupport internal audits, external audits, regulatory inspections, and compliance assessments by providing objective evidence and subject matter expertise related to software lifecycle and design control processes.\nDrive continuous improvement activities and support investigations, CAPAs, and compliance initiatives related to software products and processes.\nServe as a software compliance and design assurance subject matter expert, partnering with cross-functional teams to ensure quality and compliance considerations are integrated throughout product development and maintenance activities.\nSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.\nComplies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.\nQUALIFICATIONS\nEducation\nBachelors Degree (±16 years) in an Engineering or Technical Field\n(OR)\nAn equivalent combination of education and work experience\nExperience/Background\nMinimum 7 years of Software Quality Engineering experience. \nDetailed knowledge of IEC 62304, ISO 14971, ISO 13485, FDA Design Controls, FDA Computer Software Assurance (CSA), Medical Device Cybersecurity Guidance, Software Validation Principles, IEEE 1012. \nAdvanced computer skills, including statistical/data analysis and report writing skills. \nAdvanced Information Technology and data mining skills. \nPrior medical device experience preferred. ASQ CSQE certification desired.\nExperience working in a broader enterprise/cross-division business unit model preferred. \nAbility to work in a highly matrixed and geographically diverse business environment. \nAbility to work within a team and as an individual contributor in a fast-paced, changing environment. \nAbility to leverage and/or engage others to accomplish projects. \nStrong verbal and written communications with ability to effectively communicate at multiple levels in the organization. \nMultitasks, prioritizes and meets deadlines in timely manner. \nStrong organizational and follow-up skills, as well as attention to detail.\n Ability to travel approximately 5-25%, including internationally.\nThe base pay for this position is\n$90,000.00 - $180,000.00In specific locations, the pay range may vary from the range posted.\nJOB FAMILY:\nOperations QualityDIVISION:\nCRM Cardiac Rhythm ManagementLOCATION:\nUnited States > Sylmar : 15900 Valley View CourtADDITIONAL LOCATIONS:\nWORK SHIFT:\nStandardTRAVEL:\nYes, 5 % of the TimeMEDICAL SURVEILLANCE:\nNot ApplicableSIGNIFICANT WORK ACTIVITIES:\nContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf","description_format":"text","description_chars":6680,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Retirement plans"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Information Security","Cardiovascular Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-11-06T23:29:58Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":3,"expected_fill_days":29,"reasons":["conf:0","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-07T05:47:08Z"},"pay":{"stated_usd_annual":180000,"is_top_pay":true},"html_url":"https://alion.io/job/abbott-senior-software-quality-engineer","json_url":"https://alion.io/job/abbott-senior-software-quality-engineer.json","meta":{"generated_at":"2026-11-07T21:36:15Z","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":35049,"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":2710},"rest":"https://alion.io/mcp/rest/get_company?id=2710"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fabbott-senior-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%2Fabbott-senior-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%2Fabbott-senior-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/abbott-senior-software-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabbott-senior-software-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3897287}},{"tool":"search_jobs","arguments":{"company":"abbott.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3897287},"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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