{"id":1699899,"url":"https://alion.io/job/hologic-capa-facilitator-engineer","title":"CAPA Facilitator, Engineer","company":{"id":720267,"name":"Hologic","domain":"hologic.com","url":"https://alion.io/company/hologic","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":82,"open_postings":14,"ghost_share":0,"stale_share":0.714,"repost_share":0,"time_to_fill_p50_days":38,"computed_at":"2026-10-30T05:48:23Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Newark, United States","Marlborough, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":78000,"max_usd":143000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"CAPA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-08-17T12:36:31Z","employer_posted_date":"2026-08-17","last_verified_at":"2026-10-31T04:24:31Z","board_verified":true,"closed_at":null,"days_open":74,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":74},"description":"Hologic is seeking a Quality Engineer, CAPA Facilitator to support and strengthen Corrective and Preventive Action, CAPA, processes and broader quality assurance operations. This role will partner closely with Quality Management System, QMS, leadership and cross-functional teams to improve CAPA performance, support remediation efforts, build CAPA competency, and help sustain effective quality systems.\nThe ideal candidate brings strong experience in quality assurance within a regulated environment, particularly medical device, IVD, or pharmaceutical, and has demonstrated expertise in CAPA, root cause analysis, quality metrics, audit support, and continuous improvement.\nKey Responsibilities CAPA System Leadership and Support\nServe as a subject matter expert for CAPA, including root cause analysis, effectiveness checks, and sustainable corrective actions.\nCoordinate and facilitate CAPA Review Board meetings and related documentation.\nOwn and improve the divisional CAPA toolbox, including training materials, templates, and reference resources.\nMonitor CAPA system health, conduct daily reviews for escalations, and coordinate with departments to support adequate resourcing.\nProvide input into global CAPA process improvements and related training content.\nQuality Assurance Operations\nSupport and model Hologic’s quality values while promoting a culture of accountability, compliance, and continuous improvement.\nCollaborate with junior staff, peers, and cross-functional stakeholders across multiple organizational levels.\nAssist in the development, implementation, and maintenance of quality assurance procedures, processes, and documentation.\nProactively identify opportunities to strengthen QMS processes, including inputs to and outputs from CAPAs.\nAnalyze quality data and trends to identify improvement opportunities and systemic risks.\nDevelop and maintain CAPA and quality metrics, dashboards, and reporting tools.\nRoutinely partner with internal suppliers and stakeholders to review CAPA data, monitoring, and performance.\nAudit and Compliance Support\nParticipate in and support internal and external audits, including FDA inspections, as a CAPA and quality systems subject matter expert.\nAssist with audit preparation, data collection, and communication with functional areas to support audit readiness and efficiency.\nHelp ensure compliance with applicable FDA regulations, QMSR, ISO 13485, and other relevant global quality standards.\nTraining and Mentorship\nMentor and coach junior team members in CAPA and quality system fundamentals.\nProvide consultation and training on CAPA principles, methodologies, and best practices to QMS and cross-functional teams.\nContinuous Improvement and Special Projects\nLead or contribute to CAPA-related remediation projects and continuous improvement initiatives.\nSupport data analysis activities to develop key performance indicators across functions.\nReview open Quality Plans, QPLs, and provide recommendations for updates or improvements.\nQualifications Education\nTechnical Bachelor’s degree or higher preferred.\nExperience\n3-8 years of experience in the medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems.\nExperience with Agile or an equivalent Product Lifecycle Management system is beneficial.\nSkills and Knowledge\nStrong working knowledge of QMSR, ISO 13485, and global quality regulations.\nDemonstrated ability to lead cross-functional teams and manage multiple workstreams.\nExcellent technical writing, analytical, and problem-solving skills.\nStrong interpersonal and communication skills, including the ability to provide executive-level updates and support regulatory documentation.\nDetail-oriented, highly organized, proactive, and comfortable working in a dynamic environment.\nAbility to present materials to director-level leadership.\nUnderstanding of statistics and statistical analysis.\nSo why join Hologic?\nWe are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.\nIf you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!\nThe annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.\nAgency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.\nHologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.\nLI-#DS1","description_format":"text","description_chars":5262,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Hospitals & Health Systems"],"lifecycle":[{"event":"open","at":"2026-10-02T13:01:36Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 30 · green card filings: 7","filings_12m":30,"filings_prev_12m":31,"green_card_filings_12m":7,"median_offered_wage_usd":133986,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":15,"band":"cold","label":"Long shot","p_open":1,"p_active":0.412,"p_room":0.36,"age_days":74,"expected_fill_days":38,"reasons":["conf:1","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/hologic-capa-facilitator-engineer","json_url":"https://alion.io/job/hologic-capa-facilitator-engineer.json","meta":{"generated_at":"2026-10-31T06:03:51Z","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":8794,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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":720267},"rest":"https://alion.io/mcp/rest/get_company?id=720267"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhologic-capa-facilitator-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%2Fhologic-capa-facilitator-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%2Fhologic-capa-facilitator-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/hologic-capa-facilitator-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhologic-capa-facilitator-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1699899}},{"tool":"search_jobs","arguments":{"company":"hologic.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1699899},"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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