Principal Device Quality Engineer

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $150.9k - $155k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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HeartFlow, Inc

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2010

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

HeartFlow, Inc. is a company pioneering in the field of cardiovascular diagnostics and care, utilizing advanced medical imaging and artificial intelligence. It offers a non-invasive personalized cardiac test that provides visualization of coronary arteries, allowing physicians to develop effective treatment plans for heart disease, which is the leading cause of death. HeartFlow’s technology combines human expertise and AI-powered tools to offer physicians critical insights without the need for invasive procedures, thus enhancing safety and efficiency in cardiovascular care. The company's solutions, such as the FFR CT Analysis, are widely adopted among top hospitals, delivering accurate and timely assessments of heart health.

📋 Description

• Own the global CAPA subsystem and act as process owner and SME for Non-Conformance and CAPA processes • Execute complex investigations and serve as lead CAPA reviewer • Monitor CAPA and NC KPIs and quality dashboards, and communicate required measures to owners and management • Lead transition and integration of CAPA processes to meet evolving regulatory focus areas • Facilitate and lead CAPA Review Boards, including problem definition, investigations, and effectiveness checks • Deliver CAPA and NC training across the company • Mentor R&D, Manufacturing, and Supplier Quality owners on root cause analysis, investigations, effective actions, and robust documentation • Lead complex, high-risk investigations using root cause analysis tools • Partner with the QE team to link NC/CAPA investigations with the ISO 14971 Risk Management File • Act as CAPA and NC SME during FDA, Notified Body, and MDSAP audits • Perform internal mock audits of QMS subsystems • Lead cross-functional teams and drive systemic quality improvements ensuring compliance with FDA, ISO, and EU MDR requirements

🎯 Requirements

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Industrial) or a related Life Science discipline • 8+ years of Quality Engineering or QMS related experience in Medical Devices (Class II/III) with CAPA expertise • Demonstrated experience interacting with regulatory bodies (FDA, TUV, BSI, etc.) during inspections • Deep working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 (Risk Management), and EU MDR • Proficiency in tools such as Tableau and Minitab for trending data and verifying effectiveness checks • Proven ability to drive results and enforce quality standards with cross-functional teams without direct reporting lines • Exceptional ability to write clear, concise, and technically accurate investigation summaries • Experience with root cause analysis, CAPA, non-conformance, QMS, audits, and risk management • Master’s degree or Advanced Certification (e.g., ASQ CQE, CQA, Six Sigma Black Belt) preferred

🏖️ Benefits

• Cash bonus • Equity • Travel up to 15%