{"id":3703846,"url":"https://alion.io/job/trisalus-life-sciences-senior-quality-engineer","title":"Senior Quality Engineer","company":{"id":3783091,"name":"Trisalus Life Sciences","domain":"trisaluslifesci.com","url":"https://alion.io/company/world-3783091","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":["Westminster, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":100000,"max":120000,"currency":"USD","period":"year","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"ISO 10993","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Microsoft Excel","optional":false},{"name":"Minitab","optional":false},{"name":"Outlook","optional":false},{"name":"SharePoint","optional":false},{"name":"Statistical Process Control","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-11-03T20:23:11Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-08T23:35:51Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Serve as a technical authority and subject matter expert for quality engineering activities across the product lifecycle at TriSalus Life Sciences. The Sr. Quality Engineer provides senior-level technical leadership, mentors junior quality engineers, drives enterprise-wide quality system improvement initiatives, and leads complex cross-functional projects to ensure full alignment with FDA regulations, ISO 13485 requirements, and all applicable standards. This role is distinguished from entry level Quality Engineers by its broader organizational influence, independent project ownership, and role as an internal expert and escalation resource.\nSupplier Controls: Own and lead the supplier quality management program enterprise-wide. Define supplier performance standards, manage the supplier performance monitoring workstream, and drive corrective action activities to prevent recurrence. Develop and execute the supplier management audit schedule; serve as the primary escalation point for critical supplier non-conformances. Provide strategic recommendations for supplier qualification and disqualification decisions.\nManufacturing Quality Engineering: Serve as the technical authority for manufacturing quality. Lead the development of inspection plans, drive advanced root cause analysis for complex defects, and own continuous improvement initiatives with Sustaining Engineering. Independently assess and resolve systemic quality issues impacting production performance.\nProcess Validation / Monitoring: Lead and own process validation and monitoring programs, including IQ/OQ/PQ, Test Method Validation, and Gage R&R. Develop Quality Plans and implement statistically-based product and process quality monitoring. Serve as the internal expert and escalation resource for validation activities across the organization.\nSterility Assurance: Serve as the organizational subject matter expert for TriSalus sterility assurance compliance. Own the technical relationship with contract sterilization and testing services. Lead process change control, deviation management, BI testing oversight, and periodic requalification/revalidation. Advise R&D and Operations on sterilization strategy and regulatory guidance for new and existing products.\n External Standards: Manage the External Standards workstream. Ensure that the External Regulatory Documents applicable to the TriSalus medical device business (EXT-0001) document is maintained and current based on notifications from regulations and standards publication suppliers. Submit new/revised standards into Veeva Vault in a timely fashion. Help assign and/or perform gap assessments and implement changes for revised standards that impact TriSalus devices..\nCalibration: Lead the development and continuous improvement of in-house calibration capabilities. Define equipment requirements, draft and approve procedures, and oversee training and execution of calibration activities in collaboration with R&D and Operations.\n\nInternal Audit: Participate in the internal audit program, including serving as lead auditor and audit program owner. Ensure timeliness objectives are met and quality records are properly maintained. Mentor junior engineers in audit methodology.\nNon-Conforming Materials: Drive timely investigation, disposition, and execution activities. Provide performance metrics and trend analysis to leadership; ensure all NCR quality records are properly maintained.\nCorrective and Preventive Actions:. Identify systemic quality issues and trends, lead root cause analysis, and manage corrective and preventive actions to ensure Quality Objectives are met. Provide performance metrics and ensure proper documentation.\nRoot Cause Analysis / Statistical Techniques: Serve as the organizational expert in root cause analysis and statistical tool applications. Provide training and coaching across the quality and operations organizations.\nComputer Software Assurance: Lead or provide senior technical oversight to CSA activities. Collaborate with Operations and R&D on software validation and monitoring, including software assessment and revision control.\nGeneral:\nServe as a key participant and technical leader during regulatory site audits (front/back room).\nGenerate, review, and approve Quality Plans; provide final sign-off on complex validation and quality documents.\nGenerate change orders to ensure procedures comply with current processes and regulations; approve changes initiated by others.\nPrepare and present metrics, trend analysis, and strategic recommendations during Management Review meetings.\nMentor and develop Sr. Quality Engineers and Associate Quality Engineers; support their professional growth and technical capability.\nPerform final traveler review and finished device release to finished goods as needed.\n\n Education & Certifications:BS in Engineering, Science, Biomedical, or related field required.\nCQA or Lead Assessor certification required.\nCQE certification preferred.\nASQ Certified Quality Engineer (CQE) or equivalent strongly preferred\nValid passport required.\n\nWork Experience:8+ years of Quality Engineering experience in the medical device, pharma, or combination product industry.\nDemonstrated experience leading quality programs, owning complex workstreams, and serving as a technical authority.\nExperience in the manufacture of medical devices or pharmaceuticals required.\nExperience mentoring or developing junior quality engineering staff.\nExperience with intravascular devices a plus.\nExperience with drug product manufacturing a plus\n\n Knowledge, Skills & Abilities:Deep knowledge and application of US and international standards: FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 10993, ISO 11135, ISO 11607, ISO 11737, and ISO 14644.\nExpert-level application of root cause analysis, statistical techniques, SPC, DOE, and problem-solving methodologies.\nAbility to independently lead complex, cross-functional quality projects with minimal supervision.\nStrong technical writing skills; ability to author, review, and approve quality system documents.\nAdept in Microsoft Excel, Minitab, Word, PowerPoint, SharePoint, Outlook, and Teams.\nDemonstrated ability to influence across functions and drive quality culture at an organizational level.\nExcellent communication skills (oral and written); able to present to senior leadership and regulatory authorities.\nStrong sense of urgency, attention to detail, and ability to manage multiple high-priority workstreams simultaneously. \n\nPhysical Requirements:\nAbility to safely and successfully perform essential job functions consistent with ADA, FMLA, and applicable federal, state, and local standards.\nAbility to maintain regular, punctual attendance consistent with ADA, FMLA, and applicable standards.\nMust be able to lift and carry up to 30 lbs.\nMust be able to talk, listen, and speak clearly on telephone and video conference.\nMust be able to travel overnight and internationally (","description_format":"text","description_chars":6941,"description_truncated":false,"requirements":{"experience_years_min":null,"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":["Drug Discovery","Cancer Care Centers"],"lifecycle":[{"event":"open","at":"2026-11-03T20:23:11Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":29,"reasons":["conf:3","win:early"],"computed_at":"2026-11-08T05:47:12Z"},"pay":{"stated_usd_annual":120000,"is_top_pay":false},"html_url":"https://alion.io/job/trisalus-life-sciences-senior-quality-engineer","json_url":"https://alion.io/job/trisalus-life-sciences-senior-quality-engineer.json","meta":{"generated_at":"2026-11-09T03:01:23Z","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":761,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-10T00:00:00Z"}},"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":3783091},"rest":"https://alion.io/mcp/rest/get_company?id=3783091"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ftrisalus-life-sciences-senior-quality-engineer"},{"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%2Ftrisalus-life-sciences-senior-quality-engineer"},{"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%2Ftrisalus-life-sciences-senior-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/trisalus-life-sciences-senior-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ftrisalus-life-sciences-senior-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3703846}},{"tool":"search_jobs","arguments":{"company":"trisaluslifesci.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3703846},"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); 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