{"id":2388463,"url":"https://alion.io/job/hologic-principal-post-market-quality-engineer","title":"Principal Post Market Quality 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":83,"open_postings":12,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":38,"computed_at":"2026-10-17T05:46:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","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"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":125000,"max_usd":255000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1695},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-12T18:07:09Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-17T20:11:07Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"The Principal Post Market Quality Engineer serves as the senior technical authority for Post Market Quality Assurance, leading integrated, compliant, and risk-based post-market processes across Breast & Skeletal Health Solutions product lines to ensure patient safety, regulatory compliance, and continuous quality system improvement.\nKnowledge\nExpert understanding of Post Market Quality Assurance processes across complaint handling, complaint investigation, medical device reporting, reportability, health risk assessment, and post-market data analysis/trending.\nDeep knowledge of medical device regulations and quality system requirements, including:21 CFR Part 820 / QMSR\n21 CFR Part 803\n21 CFR Part 806\n21 CFR Parts 1000-1050\nISO 13485\nISO 14971\nEU MDR vigilance requirements\nMDSAP\n\nStrong understanding of FDA, Notified Body, and MDSAP inspection expectations.\nKnowledge of risk management, health risk assessment, Health Hazard Evaluation, patient impact assessment, and risk acceptability.\nKnowledge of how Post Market processes interact with design, manufacturing, CAPA, nonconformance, field actions, and overall quality system remediation.\nUnderstanding of statistical methods, trending, signal detection, and emerging-risk evaluation.\nAwareness of evolving global regulations, guidance, and industry practices.\nPreferred knowledge of Salesforce-based complaint systems, Agile or other electronic QMS systems, test method validation, design of experiments, and reliability analysis.\nSkills\nServes as a senior technical authority and subject matter expert across PMQA processes.\nDesigns, improves, and governs procedures, decision trees, forms, templates, and technical documentation.\nMakes and defends risk-based technical and process decisions under regulatory scrutiny.\nLeads gap assessments, remediation activities, process improvements, retrospective reviews, and verification of effectiveness.\nProvides technical direction to process leads and cross-functional teams without direct authority.\nSupports complex complaint investigations, root cause analysis, escalation decisions, reportability assessments, CAPA, nonconformance, and field action evaluations.\nEnhances post-market data analysis, trending, and signal detection methods.\nEvaluates potential use of artificial intelligence in Post Market processes, including benefit, risk, validation, and regulatory compliance considerations.\nRepresents PMQA during inspections and audits, including readiness preparation, storyboards, observation responses, and corrective actions.\nCommunicates effectively with executives, regulators, inspectors, technical teams, and cross-functional partners.\nCoaches, mentors, and trains engineers, specialists, and process leads.\nPreferred certifications include ASQ CQE, CRE, or CQA.\nBehavior\nActs with complete autonomy and independent judgment on complex, high-risk, or unique assignments.\nDemonstrates technical leadership without direct supervisory responsibility.\nOperates with urgency to identify, escalate, and resolve quality issues.\nInfluences without authority and builds credibility with senior leaders, process owners, regulators, and cross-functional partners.\nThinks systemically, ensuring PMQA processes operate as an integrated, compliant, and sustainable system.\nUses sound judgment when evaluating ambiguous data, intangible factors, and regulatory risk.\nMaintains consistency in methods, decision criteria, and documentation across processes, sites, and product lines.\nModels Hologic and BSHS quality values while protecting patient safety and the Hologic brand.\nBuilds formal networks across functions to support quality objectives and organizational goals.\nCoaches others and builds organizational capability through mentoring and training.\nExperience\nBachelor’s Degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.\nAdvanced degree preferred.\nRequired experience level:Bachelor’s degree with 10+ years of relevant experience, or\nMaster’s degree with 8+ years of relevant experience, or\nPhD with 5+ years of relevant experience.\n\nExperience should be in medical device quality engineering or a related field.\nMinimum 8 years of direct Post Market experience.\nHands-on depth required in at least two of the following areas, with working knowledge of all:Complaint handling and investigation\nMedical device reporting\nHealth risk assessment\nData analysis and trending\n\nStrongly preferred experience supporting FDA inspections and responding to inspectional observations.\nPreferred experience with capital equipment, radiation-emitting products, and single-use or sterile devices.\nExperience leading or supporting quality system remediation and improvement programs.\nExperience providing technical leadership across product lines, sites, and cross-functional teams.\nWhy join Hologic?\nWe are committed to making Hologic the destination for top talent. 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.\nThe annualized base salary range for this role is $138,000 - $230,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.\nAgency and Third-Party Recruiter Notice\nAgencies 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.","description_format":"text","description_chars":5897,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Diagnostic Tests & IVD","Medical Imaging Systems","Women’s Health & Maternity"],"lifecycle":[{"event":"open","at":"2026-10-12T20:35:28Z"}],"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":"2026-10-15T11:24:14+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":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":4,"expected_fill_days":38,"reasons":["conf:5","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-10-17T05:46:00Z"},"pay":null,"html_url":"https://alion.io/job/hologic-principal-post-market-quality-engineer","json_url":"https://alion.io/job/hologic-principal-post-market-quality-engineer.json","meta":{"generated_at":"2026-10-18T00:33:18Z","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":984,"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":720267},"rest":"https://alion.io/mcp/rest/get_company?id=720267"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhologic-principal-post-market-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%2Fhologic-principal-post-market-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%2Fhologic-principal-post-market-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/hologic-principal-post-market-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhologic-principal-post-market-quality-engineer"}]}