MRI Device Quality Engineer – 510(k) Ownership

Adialante; Menlo Park (CA); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Comprehensive health and dental cover

401(k) with company match (100% on 3%…

Daily lunch provided

Monthly gym membership reimbursement

PTO: Unlimited

Job summary

Adialante is seeking a Senior Quality Engineer to own the quality system for a mid-field MRI project and to drive toward a 510(k) submission. You will stand up the QMS, design controls, and risk management, and work cross-functionally to align regulatory strategies with engineering goals.

You will lead verification/validation, maintain the DDF, write SOPs, and manage NCRs/CAPAs through closure, ensuring traceability to regulatory standards. This role demands hands-on leadership from day one.

Qualifications

• BS or higher in engineering or a related field
• At least 5 years of experience in quality engineering for medical devices
• Hands-on design-control and risk-management work
• Working knowledge of ISO 13485, ISO 14971, IEC 62304
• Familiarity with ISO 60601-1, 60601-2-33 (MRI) and MRI-related NEMA standards
• Working knowledge of FDA design controls (21 CFR 820.30), 21 CFR 820, MDR/recall requirements, and 510(k) process
• Ability to read, analyze, and interpret engineering drawings and technical/regulatory documents

Responsibilities

• Stand up and maintain QMS aligned to ISO 13485 and FDA QMSR (21 CFR 820)
• Lead design verification and validation activities and keep DDF complete, current, and audit-ready
• Own risk management per ISO 14971 and lead risk management reviews
• Author and maintain SOPs, work instructions, and quality plans
• Own and drive NCRs, CAPAs, deviations, and design change records through closure
• Lead preparation for 510(k) submission and related documentation
• Advise leadership on regulatory strategy and quality risk
• Lead internal audits and host external audits and inspections
• Provide quality guidance across engineering and other functions

Skills

Problem solving

Attention to detail

Cross-functional leadership

Regulatory strategy

Documentation

Communication

Education

Bachelor's degree in engineering

Job description

Adialante is seeking a Senior Quality Engineer to own the quality system for a mid-field MRI project and to drive toward a 510(k) submission. You will stand up the QMS, design controls, and risk management, and work cross-functionally to align regulatory strategies with engineering goals.

You will lead verification/validation, maintain the DDF, write SOPs, and manage NCRs/CAPAs through closure, ensuring traceability to regulatory standards. This role demands hands-on leadership from day one.