{"id":2826816,"url":"https://alion.io/job/triple-ring-technologies-manager-quality-assurance","title":"Manager, Quality Assurance","company":{"id":4392583,"name":"Triple Ring Technologies","domain":"tripleringtech.com","url":"https://alion.io/company/tripleringtech","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":75,"open_postings":5,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Solutions","role_family":"Solutions","seniority":"middle","employment_type":null,"work_mode":"hybrid","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":{"min":125000,"max":150000,"currency":"USD","period":"year","gross":null,"usd_annual":150000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":true},{"name":"Machine Learning","optional":true},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-06-18T23:41:39Z","employer_posted_date":"2026-07-24","last_verified_at":"2026-10-21T06:16:09Z","board_verified":true,"closed_at":null,"days_open":124,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":124},"description":"Triple Ring Technologies, Inc. offers a unique environment for talented individuals interested in undertaking varied technical challenges, primarily in medical device and life science industries. Headquartered in Newark, CA, we are an innovative research and development company that partners with clients to deliver complex technical solutions. Our highly interdisciplinary team includes senior professionals from industry, finance, and academia, with extensive experience in medical device, life science, clean tech, security, and industrial technologies. We rely upon each other for technical excellence, real-world engineering and commercial wisdom. Learn more at www.tripleringtech.com.\nJob Summary\nThe Manager of Quality Assurance will maintain and lead the implementation of Triple Ring’s Quality Management System (QMS) for client projects. He/she will work collaboratively with project leadership and other team members to develop, coordinate, and own the QMS elements of a project. These will include all applicable QMS deliverables related to product planning, design and development of hardware, software, and AI/ML-enabled systems, engineering builds, clinical builds, and transfer to manufacturing.\nResponsibilities\nProvide project teams with the guidance necessary to maintain a high level of ISO13485:2016 QMS compliance, with specific focus on hardware, software and system design assurance activities.\nEnsure that medical device design project quality planning is consistent with project objectives and delivers a Quality Management Responsibilities Plan for individual projects as needed\nEnsure that medical device design project quality activities are efficient and effective and performed in a proactive manner\nOversee the generation and maintenance of quality records that are consistent with Triple Ring’s QMS\nEnsure that quality records are maintained in a state of readiness for external audits and regulatory inspections\nMaintain and regularly update Triple Ring’s library of applicable technical, quality, and risk management standards\nMaintain Triple Ring’s ISO13485:2016 certification, including managing and conducting internal audits\nDevelop SOPs, work instructions, guidance documents and templates to drive compliance and to facilitate dissemination of best practices related to ISO13485:2016 quality management systems\nSupport and manage ISO13485:2016QMS related training and professional development for Triple Ring scientific and technical staff\nOwn the Management Review process, managing and reporting project and operational quality metrics to management\nProvide input to quality-related planning to meet short and long term business goals\nProvide management with objective evaluation of overall quality performance and guidance for implementation of improvements\nActively participate in developing and deploying effective continuous improvement of Triple Ring’s quality management processes\nServe as the ISO13485:2016 QMS Management Representative, interfacing with the ISO Registrar and with Regulatory Agencies as necessary\nManage Triple Ring’s Document Control function and related personnel\nEducation, Experience, and Skills\nExpert in medical device design assurance activities, including design controls, risk management, software development lifecycle, design reviews, design transfer and medical device regulatory submissions.\nDemonstrated hands-on experience personally executing and reviewing design assurance deliverables-design controls, Design History File (DHF) and requirements traceability, risk management, and verification and validation (V&V)-for hardware, software, and AI/ML-enabled medical devices; this is a hands-on technical role, not an oversight- or audit-only function.\nMinimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced degree preferred\nISO 13485 - Lead Assessor Certification required. Other ASQ and RAPS Certifications are a plus (e.g., Certfifed Quality Auditor, Certified Quality Engineer, Certified Quality Manager-Operational Excellence)\nExperience hosting external audits and regulatory inspection as primary audit guide a must.\nStrong understanding and application of the following medical device standards is required.ISO 13485:2016,\nISO14971:2019,\nISO/IEC62304:2006,\nIEC60601-1/IEC61010\n\nIn-depth knowledge of current regulatory expectations, quality and compliance processes, operations and strategy related to medical device development lifecycle, from ideation to commercial distribution.\nPrevious experience collaborating with medical device submission, such as US FDA 510(K) and PMA is required.\nDemonstrated knowledge of interpretation and application of 21CFR820 QMSR. Understanding of EU-MDR and other MDSAP OUS regions a plus.\nWorking understanding of GCP clinical investigation and validation activities.\nMinimum three (3) years of active medical device quality engineering or design assurance background, with additional 2 years of quality leadership experience;\nStrong Experience in design, manufacturing, process validation for medical devices or other technically complex or regulated products\nWorking knowledge of engineering design and build practices\nWorking knowledge of basic assembly and manufacturing processes\nProgressive QA/QC leadership experience, including “hands-on” detailed quality systems development and experience managing implementation of quality functions and related personnel\nDemonstrated leadership of design assurance across concurrent hardware, software, and AI/ML workstreams within a single device program, including setting strategy and reviewing deliverables produced by project engineers\nExperience implementing electronic Quality Management System (eQMS) and other relevant computer system validation (CSV) /computer system assurance (CSA) activities.\nComfortable with electronic documentation/records systems (e.g., Windchill, Helix) and strong general office computing skills, including experience with creating Microsoft Office templates and using AI Tools.\nDesired skills: \nHands-on experience standing up or maturing design assurance for AI/ML-enabled SaMD, including dataset and data-provenance controls, model verification and validation, and ongoing algorithm performance monitoring\nExperience defining and executing software and algorithm verification and validation (V&V) strategy traceable to design inputs, hazard analysis, and risk controls, including IEC 62304 software safety classification\nIEC 81001-5-1 (health software security) and AI/ML governance frameworks-FDA Good Machine Learning Practice (GMLP), AAMI CR34971/TR34971, and ISO/IEC 42001-a plus\nPrevious direct medical device submission responsibility as primary sponsor is a plus\nOur benefit program includes: flexible time off, paid holidays, 401(k) plan with employer match, bonus, equity, a variety of medical, dental and vision plan options, and more.\nThe annual salary range for jobs which are performed in US, California is $125,000 to $150,000. Please note that the salary range is a guideline and compensation may vary based on factors such as qualifications, skill level, experience, competencies and work location.\nThis role will be eligible for our hybrid work model which requires working onsite a minimum of 3 days per week: Tuesday, Wednesday, and 1-day of your choice. In certain circumstances the hybrid work model may change to accommodate business needs.\nTriple Ring Technologies is an Equal Employment Opportunity Employer and is committed to workforce diversity, providing equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.\nTriple Ring Technologies complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, please email .","description_format":"text","description_chars":8089,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Flexible time off","Hybrid work","Professional development"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Science & Engineering"],"lifecycle":[{"event":"open","at":"2026-10-18T23:19:55Z"}],"visa":[],"liveness":{"score":9,"band":"cold","label":"Long shot","p_open":1,"p_active":0.312,"p_room":0.28,"age_days":124,"expected_fill_days":32,"reasons":["conf:3","win:tail","crowd:"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":150000,"is_top_pay":false},"html_url":"https://alion.io/job/triple-ring-technologies-manager-quality-assurance","json_url":"https://alion.io/job/triple-ring-technologies-manager-quality-assurance.json","meta":{"generated_at":"2026-10-21T06:26:25Z","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":9215,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"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":4392583},"rest":"https://alion.io/mcp/rest/get_company?id=4392583"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ftriple-ring-technologies-manager-quality-assurance"},{"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%2Ftriple-ring-technologies-manager-quality-assurance"},{"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%2Ftriple-ring-technologies-manager-quality-assurance"},{"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/triple-ring-technologies-manager-quality-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ftriple-ring-technologies-manager-quality-assurance"}]}