Senior Quality Engineer
About the role
Senior Quality Engineer to own quality on a mid-field MRI system, drive toward a 510(k) submission, stand up and run the quality management system, design controls, and risk management. Hands-on, cross-functional with engineering, and responsible for regulatory strategy and submission readiness.
Responsibilities
- Stand 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-ready
- Own 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 records
- Author and maintain SOPs, work instructions, and quality plans that close compliance gaps before they become problems
- Own and drive NCRs, CAPAs, deviations, and design change / change order (CO) records through to closure
- Perform 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 standards
- Lead preparation of the 510(k) submission and the design/quality documentation behind it
- Advise leadership on pre- and post-market regulatory strategy and quality risk
- Lead in-house audits and testing, and prepare for, host, and act as primary point of contact for external audits and inspections
- Provide quality guidance across engineering and other functional groups, identify the root sources of quality problems, and design corrective action programs
Qualifications
- Bachelor of Science or higher in engineering or a related field
- At least 5 years of experience in quality engineering / quality assurance for medical devices, including hands-on design-control and risk-management work
- Working 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 standards
- Working knowledge of FDA design controls (21 CFR 820.30), 21 CFR 820 (QMSR), MDR/recall requirements, and the 510(k) process
- Ability to read, analyze, and interpret engineering drawings and technical, scientific, and regulatory documents
Skills
Benefits
- Comprehensive health and dental coverage
- 401(k) with company match (100% on first 3% contributed, 50% on next 2%, up to 4% total)
- Daily lunch provided
- Monthly gym membership reimbursement
- PTO: Unlimited
About Adialante
Cancer screening without barriers
We know how to improve cancer outcomes by 8x-10x: you catch it early. MRI is the most robust and powerful cancer-detection tool in the world, yet systems cost millions to purchase, take months to install, and require high levels of technical skill to operate. We've redesigned MRI from the ground up with new physics, algorithms, and hardware, all to bring cancer screening to the entire world. Our mobile MRI is an imaging clinic on wheels. No equipment to buy, no infrastructure needed. For a flat per-scan fee, any medical site can offer MRI cancer screening. Starting with prostate cancer. Then everything else.
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