{"id":3847687,"url":"https://alion.io/job/hologic-post-market-surveillance-engineer-2","title":"Product Quality Engineer 2","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":"2026-11-10T06:52:35Z"}},"role":"Hardware","role_family":"Hardware","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":["Marlborough, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design of Experiments","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 10993","optional":false},{"name":"ISO 13485","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-11-05T22:34:37Z","employer_posted_date":"2026-11-09","last_verified_at":"2026-11-10T10:28:42Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"The Product Quality Engineer 2 provides quality engineering support for on-market medical devices by leading complaint investigations, risk assessments, root cause analysis, and cross-functional corrective actions to ensure product quality, regulatory compliance, and continuous improvement.\nKnowledge\nMedical device quality systems and regulatory requirements, including FDA Quality System Regulations, Design Controls, ISO 13485, EU MDR, and risk management standards.\nPost-market quality processes, including complaint handling, investigations, risk assessment, Health Risk Assessments, CAPA evaluation, and change control.\nProduct design and process change requirements, including documentation updates, testing, verification and validation, and impact assessments.\nPreferred knowledge of test method validation, root cause failure analysis, statistical methods, design of experiments, reliability, electrical safety, sterilization, packaging, biocompatibility, and requirements analysis.\nSkills\nConducts complaint evaluations, investigations, root cause analysis, risk assessments, and trend analysis for on-market medical devices.\nLeads cross-functional teams to determine corrective actions, implement improvements, and support CAPA decisions.\nCommunicates investigation findings, root cause, recommended changes, and implementation scope clearly to stakeholders and leadership.\nAssesses product and project documentation for compliance and supports change control activities.\nPresents product quality metrics, investigation outcomes, and recommended resolutions to leadership.\nCoordinates Health Risk Assessment activities and supports Quality Investigation Review boards.\nPerforms field investigations at customer sites in partnership with sales, service, and field-based teams.\nBehavior\nWorks collaboratively across functions and takes ownership of investigations and quality issues.\nDemonstrates sound judgment in prioritizing complaints based on risk, trends, data, and business impact.\nOperates with intermediate autonomy, requiring limited oversight on complex issues.\nShows strong accountability, compliance mindset, and attention to detail.\nCommunicates effectively with technical teams, leadership, and field-based partners.\nApplies company policies and procedures consistently to resolve quality and product issues.\nTakes initiative to lead critical tasks and drive timely resolution.\nExperience\nBachelor’s degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.\n2-5 years of relevant engineering experience.\nExperience in an FDA-regulated industry preferred.\nExperience in root cause analysis, product development, R&D, or medical device quality engineering is beneficial.\nExperience supporting post-market medical devices, complaint investigations, CAPA evaluation, and regulated product changes is preferred.\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 $78,000 - $122,100 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":3937,"description_truncated":false,"requirements":{"experience_years_min":2,"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":"2026-11-06T01:24:19Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"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":"2026-11-10T11:34:35+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":3}],"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:2","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-10T06:52:35Z"},"pay":null,"html_url":"https://alion.io/job/hologic-post-market-surveillance-engineer-2","json_url":"https://alion.io/job/hologic-post-market-surveillance-engineer-2.json","meta":{"generated_at":"2026-11-10T11:45:46Z","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":27359,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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-post-market-surveillance-engineer-2"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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-post-market-surveillance-engineer-2"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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-post-market-surveillance-engineer-2"},{"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-post-market-surveillance-engineer-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhologic-post-market-surveillance-engineer-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3847687}},{"tool":"search_jobs","arguments":{"company":"hologic.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3847687},"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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