Senior Quality Engineer

← All openingsCareersSenior Quality EngineerAdialante | Menlo Park, CA (100% On-site)Apply for this roleor email our team at careers@adialante.comAbout AdialanteMRI is the most powerful imaging modality in medicine, yet it's inaccessible. As a result, we catch cancers too late; patients suffer; and we lose people too early. We will change that.Our team is developing breakthrough MRI technology to make clinically effective imaging accessible — giving people everywhere the ability to screen for cancers, strokes, dementia, and other disorders long before symptoms force the issue. We're fortunate to be backed by Y Combinator, the National Science Foundation, and many other great investors. If you want to disrupt the landscape of healthcare, join our team.See our launch video →About the RoleWe're looking for a Senior Quality Engineer to own quality on a mid-field MRI system as we drive toward a 510(k) submission. This is a foundational hire: you'll stand up and run the quality management system, design controls, and risk management that turn breakthrough engineering into a safe, cleared medical device — and you'll set the standard the rest of the team builds to. You'll work hands-on and cross-functionally with engineering, advise leadership on regulatory strategy, and be the person accountable for getting us to submission the right way. If you're a senior quality professional who wants ownership from day one, thrives in a fast-paced startup, and wants to see your work reach patients — this is for you. This is not your typical quality role. You will lead and shape our strategy, have true impact, and not sit on the sidelines.CompensationSalary: $130k-$165kEquity: 0.25%-0.85%, 4-year vesting, 1-year cliffRelocation assistanceBenefitsComprehensive health and dental coverage401(k) with company match (100% on first 3% contributed, 50% on next 2%, up to 4% total)Daily lunch providedMonthly gym membership reimbursementPTO: UnlimitedLocation: In-person at Menlo Park, CA officesWhat You'll DoStand up and maintain our quality management system, aligned to ISO 13485 and the FDA Quality Management System Regulation, or QMSR (21 CFR 820)Lead design verification and validation activities and keep the Design and Development File / DDF (formerly the Design History File) complete, current, and audit-readyOwn risk management per ISO 14971 — hazard analysis, risk assessments, and the risk management file — and lead risk management reviews of traceability matrices to ensure requirements are correctly linked to verification and validation recordsAuthor and maintain SOPs, work instructions, and quality plans that close compliance gaps before they become problemsOwn and drive NCRs, CAPAs, deviations, and design change / change order (CO) records through to closurePerform standards analysis and work directly with engineering on the approach to compliance for applicable safety standards (e.g., IEC 60601-1, IEC 60601-2-33 for MRI equipment, IEC 62304 for device software, and relevant MRI-related NEMA standards)Review verification objective evidence and write design inspection protocols for compliance to standardsLead preparation of the 510(k) submission and the design/quality documentation behind itAdvise leadership on pre- and post-market regulatory strategy and quality riskLead in-house audits and testing, and prepare for, host, and act as primary point of contact for external audits and inspectionsProvide quality guidance across engineering and other functional groups, identify the root sources of quality problems, and design corrective action programsWhat We're Looking ForGeneral Requirements:Work authorizationStrong problem-solving skills and exceptional attention to detailAbility to work independently and lead cross-functionally in a fast-paced startup environmentClear written and verbal communication, including the ability to write technical and regulatory documents and advise leadershipOpen to candid, constructive criticismSelf-starter comfortable operating with ambiguity and little precedentTechnical Background:Bachelor of Science or higher in engineering or a related fieldAt least 5 years of experience in quality engineering / quality assurance for medical devices, including hands-on design-control and risk-management workWorking knowledge of ISO 13485 (QMS), ISO 14971 (risk management), and IEC 62304 (medical device software life cycle)Familiarity with medical electrical equipment safety standards — IEC 60601-1, IEC 60601-2-33 (MRI), IEC 62368-1 — and MRI-related NEMA standardsWorking knowledge of FDA design controls (21 CFR 820.30), 21 CFR 820 (QMSR), MDR/recall requirements, and the 510(k) processAbility to read, analyze, and interpret engineering drawings and technical, scientific, and regulatory documentsBonus Points:Direct experience preparing for or leading FDA inspections, MDSAP audits, or ISO 13485 audits, and communicating with regulatory authoritiesFamiliarity with international regulatory frameworksHands-on experience in the MRI or medical imaging spaceExperience as the founding or first quality hire at an early-stage medical device companyWhy Adialante?Work on technology with real-world healthcare impactOwn quality end-to-end and build the QMS from the ground up rather than inheriting someone else'sA seat at the table on regulatory and product strategy as we drive to submissionDirect collaboration with experienced engineers and researchersYou'll be embedded with the team, have real room to grow, and watch your work make it into the product.ApplySend your resume directly to our team.Upload your resume, add a short message, and press send. 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