{"id":972275,"url":"https://alion.io/job/abbott-laboratories-sr-manager-quality-engineering","title":"Sr. Manager, Quality Engineering","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":"2026-11-08T05:47:12Z"}},"role":"Management","role_family":"Management","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":["Saint Paul, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":129300,"max":258700,"currency":"USD","period":"year","gross":null,"usd_annual":258700},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-09-16T18:44:27Z","employer_posted_date":"2026-09-16","last_verified_at":"2026-11-08T07:34:12Z","board_verified":true,"closed_at":null,"days_open":52,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":52},"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:\nSenior Manager, Quality Engineering\nWorking at Abbott\nAt Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.\nThe Opportunity\nThis position works out of our St Paul MN OR Plymouth, MN location for our Electrophysiology business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.\nWe are seeking a strategic and influential Senior Manager, Quality Engineering & Analytics to lead quality systems performance, quality data analytics, and continuous improvement initiatives across the organization. This leader will be responsible for transforming quality data into actionable business insights, driving compliance, and building a long-term vision for how quality data can be leveraged to improve product performance, patient safety, and business outcomes.\nThis role goes beyond traditional quality management. The successful candidate will lead a team responsible for analyzing and integrating data from complaints, CAPA, management reviews, post-market surveillance, quality metrics, manufacturing performance, and commercial data to identify trends, mitigate risk, and shape future-state quality strategies.\nThe ideal candidate combines strong quality leadership experience within the medical device industry with a passion for analytics, systems improvement, and organizational influence.\nWhat You'll Work On\nQuality Strategy & Leadership\nProvide strategic leadership and oversight for Quality Engineering and Quality Analytics functions.\nEstablish a vision for the future of quality data management, analytics, and reporting capabilities across the business.\nLead the development and execution of quality strategies that support product quality, patient safety, compliance, and operational excellence.\nServe as a key member of the quality leadership team, influencing business decisions through data-driven insights.\nBuild organizational capability by coaching, mentoring, and developing high-performing quality professionals.\nQuality Data Analytics & Business Insights\nLead the collection, analysis, interpretation, and presentation of quality performance data across the organization.\nOversee management reviews, monthly quality reviews, complaint trending, CAPA effectiveness monitoring, post-market data analysis, and key quality performance indicators.\nIntegrate data from manufacturing, commercial sales, complaints, risk management, and quality systems to identify emerging trends and opportunities.\nDevelop executive-level dashboards and reporting that provide clear visibility into product quality and business performance.\nDrive continuous improvement of reporting systems, automation tools, and analytics capabilities.\nCreate a roadmap for future-state quality analytics capabilities, leveraging data to proactively identify and mitigate risks.\nQuality Systems & Compliance\nEnsure manufacturing quality system requirements are effectively established, maintained, and continuously improved.\nMonitor and report quality system performance to executive leadership.\nLead quality system reviews and ensure compliance with applicable domestic and international regulations.\nProvide oversight of CAPA processes, complaints management, nonconformance management, and quality system effectiveness.\nDrive proactive compliance initiatives across quality operations and business functions.\nLead initiatives to improve quality processes, procedures, and automated quality systems.\nRegulatory & Audit Leadership\nServe as a primary quality representative during external regulatory inspections and audits.\nEnsure readiness for FDA, notified body, and international regulatory inspections.\nPartner with Regulatory Affairs, Manufacturing, Engineering, and Operations leadership to address compliance risks and regulatory requirements.\nEnsure quality activities comply with FDA regulations, ISO 13485, and other applicable global standards.\nCross-Functional Collaboration\nPartner with Manufacturing, Engineering, Product Development, Regulatory Affairs, Risk Management, Clinical, and Commercial teams to drive business outcomes.\nInfluence senior stakeholders and cross-functional leaders to implement quality improvements and risk mitigation strategies.\nLead enterprise-level quality initiatives across functions, sites, and business units.\nTranslate complex quality data into meaningful business recommendations that drive action.\nPeople Leadership\nRecruit, develop, and retain diverse, high-performing teams.\nEstablish performance goals aligned with organizational objectives.\nFoster a culture of accountability, collaboration, innovation, and continuous improvement.\nProvide ongoing coaching and career development for team members.\nCreate an environment focused on patient safety, quality excellence, and business partnership.\nRequired Qualifications\nBachelor's degree in Engineering, Science, Quality, or related technical discipline.\n10+ years of progressive experience in Quality Engineering, Quality Systems, Quality Assurance, or related functions within the medical device or highly regulated industry.\n5+ years of people leadership experience managing technical or quality teams.\nDemonstrated experience leading quality systems and quality compliance programs in Class II or Class III medical device environments.\nExperience with complaint handling, CAPA management, management reviews, quality metrics, and post-market quality systems.\nStrong analytical background with experience leveraging data to drive business decisions.\nKnowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, GMP requirements, and global quality standards.\nProven ability to influence stakeholders and lead cross-functional initiatives in a matrixed environment.\nExceptional communication, presentation, and executive stakeholder management skills.\nStrong project management and organizational leadership capabilities.\nPreferred Qualifications\nAdvanced degree in Engineering, Quality, Data Analytics, Business, or related field.\nExperience building or modernizing quality analytics platforms, dashboards, and automated reporting systems.\nKnowledge of statistical methods, data visualization tools, and quality data management systems.\nASQ Certifications (CQE, CQA, CMQ/OE) preferred.\nSix Sigma Green Belt, Black Belt, or equivalent continuous improvement certification.\nExperience supporting global quality operations and multi-site organizations.\nExperience working closely with commercial and post-market surveillance teams to connect customer feedback with quality strategy.\nWhat Success Looks Like\nIn this role, you will:\nEstablish a clear vision for the future of quality analytics and data-driven decision making.\nTransform quality, complaint, CAPA, and manufacturing data into proactive business intelligence.\nIdentify emerging quality risks before they impact customers or patients.\nStrengthen management review processes through meaningful, actionable insights.\nDevelop a high-performing team that is viewed as a strategic business partner.\nEnhance compliance while driving operational efficiency and continuous improvement.\nInfluence senior leadership through clear communication of quality performance and risk.\nWhat We Offer\nAt Abbott, you can have a good job that can grow into a great career. We offer:\nA fast-paced work environment where your safety is our priority\nProduction areas that are clean, well-lit and temperature-controlled\nTraining and career development, with onboarding programs for new employees and tuition assistance\nFinancial security through competitive compensation, incentives and retirement plans\nHealth care and well-being programs including medical, dental, vision, wellness and occupational health programs\nPaid time off\n 401(k) retirement savings with a generous company match\nThe stability of a company with a record of strong financial performance and history of being actively involved in local communities\nApply Now\nLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives:www.abbottbenefits.com\nFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.\nConnect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on X @AbbottNews.\nThe base pay for this position is\n$129,300.00 - $258,700.00In specific locations, the pay range may vary from the range posted.\nJOB FAMILY:\nOperations QualityDIVISION:\nEP ElectrophysiologyLOCATION:\nUnited States > Minnesota > St. Paul > Tech Center : One St Jude Medical DriveADDITIONAL LOCATIONS:\nWORK SHIFT:\nStandardTRAVEL:\nNoMEDICAL SURVEILLANCE:\nNoSIGNIFICANT WORK ACTIVITIES:\nContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)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":10503,"description_truncated":false,"requirements":{"experience_years_min":10,"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","Cardiovascular Devices","Diabetes Devices","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-09-16T18:44:27Z"}],"visa":[],"liveness":{"score":18,"band":"cold","label":"Long shot","p_open":1,"p_active":0.504,"p_room":0.36,"age_days":52,"expected_fill_days":29,"reasons":["conf:3","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-08T05:47:12Z"},"pay":{"stated_usd_annual":258700,"is_top_pay":true},"html_url":"https://alion.io/job/abbott-laboratories-sr-manager-quality-engineering","json_url":"https://alion.io/job/abbott-laboratories-sr-manager-quality-engineering.json","meta":{"generated_at":"2026-11-08T11:07:20Z","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":23888,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-09T00:00:00Z"}},"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-laboratories-sr-manager-quality-engineering"},{"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-laboratories-sr-manager-quality-engineering"},{"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-laboratories-sr-manager-quality-engineering"},{"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-laboratories-sr-manager-quality-engineering\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fabbott-laboratories-sr-manager-quality-engineering"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":972275}},{"tool":"search_jobs","arguments":{"company":"abbott.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":972275},"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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