Senior Quality Engineer

Adialante; Menlo Park (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Comprehensive health and dental

401(k) with company match

Daily lunch provided

Monthly gym membership reimbursement

PTO: Unlimited

Job summary

Adialante is seeking a Senior Quality Engineer to own quality for a mid-field MRI system toward a 510(k) submission. You will stand up and run the QMS, design controls, and risk management to enable safe, cleared medical devices.

This founder-level hire will set the standard for the team and ensure regulatory readiness from day one. You will advise leadership on regulatory strategy and lead internal audits, with hands-on collaboration across engineering.

Qualifications

• 5+ years in quality engineering/QA for medical devices with hands-on design-control and risk management.
• Working knowledge of ISO 13485, ISO 14971, and IEC 62304.
• Familiarity with IEC 60601-1, IEC 60601-2-33 (MRI), IEC 62368-1 and MRI-related NEMA standards.
• Knowledge of FDA design controls (21 CFR 820.30, 820), MDR/recall, and 510(k) process.
• Ability to read, analyze, and interpret engineering drawings and regulatory documents.

Responsibilities

• Stand up and maintain the QMS aligned to ISO 13485 and FDA QMSR.
• Lead design verification/validation and keep DHF complete and audit-ready.
• Own risk management per ISO 14971 and lead risk management reviews.
• Author and maintain SOPs, work instructions, and quality plans.
• Own NCRs, CAPAs, deviations, and design change records through closure.
• Lead external audits and prepare for FDA/ISO inspections.
• Advise leadership on regulatory strategy and quality risk.
• Provide quality guidance across engineering and other teams.

Skills

Problem solving

Attention to detail

Independent

Cross-functional leader

Regulatory writing

Regulatory strategy

Education

Bachelor of Science in engineering or related field

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