Senior Quality Engineer

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

We'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.

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

Location: In-person at Menlo Park, CA offices

What You'll Do

• 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

What We're Looking For

• General Requirements:
  • Work authorization
  • Strong problem‑solving skills and exceptional attention to detail
  • Ability to work independently and lead cross‑functionally in a fast‑paced startup environment
  • Clear written and verbal communication, including the ability to write technical and regulatory documents and advise leadership
  • Open to candid, constructive criticism
  • Self‑starter comfortable operating with ambiguity and little precedent
• Technical Background:
  • 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
• Bonus Points:
  • Direct experience preparing for or leading FDA inspections, MDSAP audits, or ISO 13485 audits, and communicating with regulatory authorities
  • Familiarity with international regulatory frameworks
  • Hands‑on experience in the MRI or medical imaging space
  • Experience as the founding or first quality hire at an early‑stage medical device company