Senior Quality Engineer for MRI Devices — Lead QMS & 510(k)

Adialante LLC; Menlo Park (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Equity 0.25-0.85%

Relocation assistance

Health and dental coverage

401(k) with company match

Daily lunch provided

Gym membership reimbursement

PTO: Unlimited

Job summary

Adialante is building breakthrough MRI technology in Menlo Park, CA and seeks a Senior Quality Engineer to own quality on a mid-field MRI system as we push toward a 510(k) submission.

You will stand up and run the QMS, lead verification and validation, and manage risk per ISO 14971 while advising leadership on regulatory strategy. This role offers ownership from day one in a fast-paced startup, with patient impact at the core of the mission.

Qualifications

• Bachelor's degree in engineering or related field and 5+ years in quality engineering for medical devices.
• Hands-on design controls and risk-management experience in medical devices.
• Experience aligning QMS practices with regulatory standards and audits.

Responsibilities

• Stand up and maintain the quality management system (QMS) aligned to ISO 13485 and FDA QMSR (21 CFR 820).
• Lead design verification and validation activities and keep Design History File (DDF) complete and audit-ready.
• Own risk management per ISO 14971 and lead reviews to ensure requirements link to verification and validation records.
• Author and maintain SOPs, work instructions, and quality plans to close compliance gaps.
• Drive NCRs, CAPAs, deviations, and design changes through to closure.
• Lead preparation for 510(k) submission and related documentation; advise leadership on regulatory strategy.

Skills

Problem-solving

Independent work

Written communication

Regulatory guidance

Team collaboration

Education

Bachelor's degree in engineering

Tools

ISO 13485

ISO 14971

IEC 62304

IEC 60601-1

FDA 21 CFR 820

Job description

Adialante is building breakthrough MRI technology in Menlo Park, CA and seeks a Senior Quality Engineer to own quality on a mid-field MRI system as we push toward a 510(k) submission.

You will stand up and run the QMS, lead verification and validation, and manage risk per ISO 14971 while advising leadership on regulatory strategy. This role offers ownership from day one in a fast-paced startup, with patient impact at the core of the mission.