{"id":3720521,"url":"https://alion.io/job/fluidai-medical-quality-engineer","title":"Quality Engineer","company":{"id":674189,"name":"FluidAI Medical","domain":"nervtechnologyincdbafluidaimedical.com","url":"https://alion.io/company/nervtechnologyincdbafluidaimedical","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Rippling","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Kitchener, Canada"],"countries":["CA"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":70000,"max":85000,"currency":"CAD","period":"year","gross":null,"usd_annual":60738},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"GMP","optional":false},{"name":"IEC 60601","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"EU MDR","optional":true},{"name":"FMEA","optional":true},{"name":"GD&T","optional":true},{"name":"IEC 62304","optional":true},{"name":"Python","optional":true}],"status":"live","first_seen_at":"2026-11-03T21:51:23Z","employer_posted_date":"2026-11-03","last_verified_at":"2026-11-09T17:13:22Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Company Description:\nFluidAI is specialized in the development and deployment of data-driven surgical solutions, with an initial focus on general and gastrointestinal surgery. Our technologies integrate medical devices, software, and artificial intelligence into platforms that address real clinical and operational challenges across the continuum of surgical care.\nWe combine continuous physiological monitoring from our proprietary sensors with comprehensive electronic health record data, creating intelligent systems that enable earlier identification of clinical deterioration and complications. Beyond patient monitoring, our platform extends to patient education and engagement tools, as well as automated documentation and coding modules - supporting care teams and driving operational efficiency.\nOur team brings together expertise across clinical practice, research, engineering, data science, manufacturing, and commercialization. We build solutions designed for real-world impact, supported by full in-house capabilities, a strong intellectual property portfolio, and partnerships with leading institutions around the world.\nWe are an equal opportunity employer and have a diverse team representation across language, ethnicity, gender and nationality.\nWhy Join FluidAI Medical?\nMission to save lives and improve patient care with technology that’s already deployed on patients in real-world settings. \nWork with a high-performing and cross-functional team that is empowered to grow, learn, and contribute across all levels of the organization.\nGain exposure across the entire technical stack, from novel sensing technologies and proprietary hardware to mobile/web software and ML algorithms.\nPersonal career-focused development and training with access to workshops, coursework, and experienced mentors/consultants.\nRegular offsite activities - past events include rafting, cottaging, axe-throwing, sports leagues, and the usual BBQ.\n Job Summary:\nDo you believe that quality and fast progress can go hand in hand? Do you enjoy solving technical problems in a fast-paced environment? Are you passionate about quality and delivering life-changing medical devices? If so, read on!\nAt FluidAI, patient safety and regulatory compliance are non-negotiable. We rely on sound judgement and a risk-based approach to meet them effectively, focussing effort where it matters most. You’ll work closely with a cross-functional team to support the development, implementation, and operation of a Quality Management System that is compliant while also being clear, efficient, and scalable. You’ll make sure our controls fit the risk, keep documentation meaningful, and help the team efficiently meet requirements. You’ll also support regulatory activities across Canada, the US, and International markets.\nThis position requires you to come into our Kitchener, ON office at least 50% of the time.\nJob Responsibilities:\nUse a risk-based approach to quality. Apply rigor where it matters most, and keep things lean where it doesn't.\nPartner with engineering and operations to ensure quality is built into product and processes\nOwn the linkage of Design Controls in all stages of the production lifecycle.\nEnsure product, material, and process specifications are clear, unambiguous, and practical for production.\nCreate test methods and strategies for existing and new products, backed by sound statistical rationale.\nPlan, execute, and analyze test method/process validations.\nLead and support component/product inspection and qualification activities.\nSupport identification, auditing, and onboarding of new suppliers to ensure compliance and business continuity.\nCreate and maintain process risk documentation in line with ISO 14971, and evaluate process risks to set appropriate controls throughout the product lifecycle\nLead investigation and timely closure of non-conformances and CAPAs.\nAssess engineering change for quality and regulatory impact, and maintain change control in a way that keeps work moving.\nSupport regulatory submissions, licence applications and amendments, and responses to regulator questions.\nSupport post-market activities, including complain handling, post-launch monitoring, and trend analysis.\nSupport the creation of Device Master Records and the transfer of processes to manufacturing\nSupport internal audits, external audits (ex: MDSAP), and interaction with testing laboratories\nLook for ways to simplify and improve the QMS, and challenge processes that add burden without reducing risk\nCollaborate with Subject Matter Experts on process validation activities to ensure consistent, repeatable, and effective processes are implemented during design and manufacturing transfer.\nMaintain and support the development of process control and monitoring to ensure effective process transfer activities and compliance\nRequired Qualifications:\nBachelor’s Degree in engineering or a science-related field.\n2-5 years of experience working in a medical device or similarly regulated environment.\nWorking knowledge of ISO13485:2016, ISO 14971, IEC 60601-1:2005, and other relevant standards.\nStrong knowledge of Quality Concepts, with the judgement to know where requirements can flex and where they can't.\nComfort making risk-based decisions with incomplete information, and the ability to clearly document and defend your rationale.\nStrong analytical skills with practical knowledge of statistical methods.\nStrong project management skills and the ability to juggle shifting priorities in a fast-moving environment\nAbility to work independently and take ownership.\nCollaborative, solutions-oriented mindset. You help the team find practical, compliant solutions instead of simply flagging problems.\nAbility to work cross-functionally with departments such as Operations, Product Development, Regulatory Affairs, R&D, and Marketing.\nStrong interpersonal, written, oral communication, and negotiation skills.\nFamiliarity with cGMP.\nExperience interacting with regulatory agencies (FDA, Health Canada, etc.) and Auditing Organizations/Testing Laboratories (TUV, Intertek, Nemko, etc.).\nPreferred Qualifications:\nMASc or MS.\nCQE, CRE, or RAC certifications.\nExperience preparing or supporting regulatory submissions\nExperience interacting with regulators, notified bodies, auditing organizations, and testing laboratories\nExperience with MDSAP audits\nThorough knowledge of Canadian, US, and International Medical Device Regulations\nExperience assessing changes for regulatory reportability\nFamiliarity with post-market surveillance, complaint handling, and adverse event reporting\nFamiliarity with IEC 62304 and software as/in a medical device\nExperience building or scaling a QMS at a startup or early-stage company\nFamiliarity with Six Sigma and/or Lean manufacturing.\nApplied knowledge of Advanced Quality tools (FMEA, GD&T, Root Cause Analysis, Mistake Proofing/Poka Yoke).\nExperience with the medical device product development lifecycle (risk management, design/process verification, and validation).\nAbility to read and interpret CAD drawings.\nExperience working in compliance risk situations.\nFamiliarity with Python or similar programming languages.\nTransparency & Hiring Practices:\nCompensation: Salary range for this position is $70,000 - $85,000 CAD annually.\nApplication Screening: All applications are screened manually. We do not use AI or AI-Augmented Applicant Tracking Systems (ATS) to screen, assess, reject, or select candidates.\nPosition Status: This job posting is for an active vacancy.","description_format":"text","description_chars":7529,"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":["Patient Monitoring","Clinical Decision Support"],"lifecycle":[{"event":"open","at":"2026-11-04T02:29:33Z"}],"visa":[],"liveness":{"score":84,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.843,"p_room":1,"age_days":5,"expected_fill_days":23,"reasons":["conf:2","win:early","comp:junior"],"computed_at":"2026-11-09T06:03:00Z"},"pay":{"stated_usd_annual":60738,"is_top_pay":false},"html_url":"https://alion.io/job/fluidai-medical-quality-engineer","json_url":"https://alion.io/job/fluidai-medical-quality-engineer.json","meta":{"generated_at":"2026-11-09T20:29:16Z","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":7706,"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":674189},"rest":"https://alion.io/mcp/rest/get_company?id=674189"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ffluidai-medical-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%2Ffluidai-medical-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%2Ffluidai-medical-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/fluidai-medical-quality-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffluidai-medical-quality-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3720521}},{"tool":"search_jobs","arguments":{"company":"nervtechnologyincdbafluidaimedical.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3720521},"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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