{"id":857389,"url":"https://alion.io/job/ketryx-qara-consultant-2","title":"QA/RA Consultant","company":{"id":678995,"name":"Ketryx","domain":"ketryx.com","url":"https://alion.io/company/ketryx","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":73,"open_postings":19,"ghost_share":0.368,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":207,"computed_at":"2026-11-04T06:34:25Z"}},"role":"QA","role_family":"QA","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":130000,"max":150000,"currency":"USD","period":"year","gross":null,"usd_annual":150000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"ISO 13485","optional":false}],"status":"live","first_seen_at":"2025-08-22T20:44:03Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-11-04T07:52:37Z","board_verified":true,"closed_at":null,"days_open":438,"trust":{"level":"ok","repost_count":1,"flags":["company_stale"],"days_open":438},"description":"Job Title: QA/RA Consultant\nEmployment Status: Full-time\nOffice Hours: Monday - Friday; hybrid schedule\nLocation: Boston, Massachusetts\nCompensation: $130,000 - $150,000, plus equity options. (Compensation dependent on experience level)\nAs a Ketryx QA/RA Consultant, you will lead quality management system implementations and regulatory compliance strategies for cutting-edge medical device clients as we scale our AI-powered compliance platform. This is a rare opportunity to shape the future of regulatory affairs. You'll have the autonomy and expertise to drive repeatable QMS deployment processes while helping shape the future of regulatory affairs through innovative technology and enabling the success of the world’s most innovative companies. We offer the opportunity to work with high-growth clients, establishing best-in-class quality systems from the ground up using our revolutionary AI platform.\nOur ideal candidate will have demonstrated success in quality systems management with 5-8 years of experience in the medical device industry. Someone who is strategic yet hands-on, passionate about regulatory excellence, and eager to leverage cutting-edge AI technology will thrive in this position. In this role, you'll have the opportunity to directly impact our mission to improve 100 million patient lives by 2030 by ensuring the highest quality standards for life-saving medical devices.\nThis position will be based in our Boston, Massachusetts office with a hybrid schedule (Monday, Tuesday, Thursday, Friday in office, Wednesday WFH option). \nAbout You:\nYou're a proven QMS expert who's successfully navigated complex medical device regulatory landscapes and is ready to scale your impact through innovative technology. You've built or significantly improved quality systems at medical device companies, consulting firms, or high-growth startups, and you're excited to combine your regulatory expertise with AI-powered tools to create something category-defining.\nResponsibilities:\nLead Quality Management System (QMS) setup and deployment for medical device clients.\nOwn and manage QMS templates and regulatory compliance frameworks.\nProvide expert consulting on ISO 13485, MDSAP, GxP, and other quality systems standards.\nScale operations to support high-growth clients.\nDevelop repeatable QMS deployment processes leveraging AI platform capabilities and automatic compliance.\nShape the future of regulatory affairs through innovative product development.\nWork independently on complex quality assurance projects requiring minimal oversight.\nEnsure customer success across the entire customer engagement lifecycle.\nRequired Skills:\n4-8 years of experience in quality systems management, management representative or senior specialist role.\nFamiliar with eQMS implementation, validation and implementation.\nDeep expertise in Quality Management System setup, sub-systems, and implementation.\nStrong knowledge of ISO 13485 and Global QMS requirements.\nExpertise in AI, Digital, and Cyber Compliance.\nDeep understanding of medical device cybersecurity.\nExperience as quality management representative in regulated environments.\nExperience with regulatory and Notified Body submission requirements.\nBackground in medical device industry quality systems.\nAbility to work independently and own complex regulatory projects.\nProven track record in consulting or client-facing roles.\nPreferred Skills:\nExperience at large medical device companies (Stryker, Medtronic, Boston Scientific).\nBackground with consulting firms specializing in QMS setup.\nStartup experience (Series A/B) with QMS implementation.\nSpecializations in cybersecurity, usability, or computer software validation.\nExperience scaling quality operations in high-growth environments.\nKnowledge of AI applications in regulatory affairs.\nSubmission experience.\nExperience working in an early stage, product-based start up.\nKeywords: ISO 13485, MDSAP, Quality Management System (QMS), Management representative, Medical device quality, QMS setup, Regulatory consulting, Quality systems manager, Computer software validation, Cybersecurity, Usability, Startup experience, Series A/B, Boston/Massachusetts, Consulting firms, Quality assurance, Medical device industry\nWhat We Offer\nCompetitive compensation\nGenerous stock options possible\nWork in an exciting field with a positive impact on the world\nOpportunity to learn and grow as part of a global team\nGenerous PTO for full-time\nKetryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances\nKetryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide. We believe that, by automating much of the documentation and quality processes, teams will be able to produce safer and more innovative medical software faster.\nKetryx is at the forefront of helping teams incorporate AI/ML into medical software and that’s why we need you!","description_format":"text","description_chars":5463,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Equity","Stock options"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Information Security","Security Compliance","Developer Tools"],"lifecycle":[{"event":"open","at":"2026-09-13T07:29:17Z"},{"event":"close","at":"2026-09-16T02:17:02Z"},{"event":"reopen","at":"2026-09-25T17:44:40Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":107500,"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)"],"filings_for_role_12m":0}],"liveness":{"score":14,"band":"cold","label":"Long shot","p_open":1,"p_active":0.509,"p_room":0.28,"age_days":438,"expected_fill_days":207,"reasons":["conf:3","win:tail","crowd:"],"computed_at":"2026-11-04T06:34:25Z"},"pay":{"stated_usd_annual":150000,"is_top_pay":true},"html_url":"https://alion.io/job/ketryx-qara-consultant-2","json_url":"https://alion.io/job/ketryx-qara-consultant-2.json","meta":{"generated_at":"2026-11-04T09:19:13Z","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":14538,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"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":678995},"rest":"https://alion.io/mcp/rest/get_company?id=678995"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fketryx-qara-consultant-2"},{"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%2Fketryx-qara-consultant-2"},{"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%2Fketryx-qara-consultant-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/ketryx-qara-consultant-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fketryx-qara-consultant-2"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":857389}},{"tool":"search_jobs","arguments":{"company":"ketryx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":857389},"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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