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HeartFlow, a publicly traded medical technology company (HTFL), is seeking a Principal Device Quality Engineer to serve as the global process owner and subject matter expert for the Corrective and Preventive Action (CAPA) and Non-Conformance (NC) subsystems. This is a strategic, high-visibility role combining process ownership, complex investigations, and continuous improvement leadership.
Key Responsibilities:
Process Ownership & Strategy: Serve as the Global Process Owner for the CAPA subsystem, ensuring actions and records are robust, effective, and compliant with FDA, ISO 13485, ISO 14971, and EU MDR requirements. Monitor subsystem health through KPI development and quality dashboards, communicating findings to CAPA owners and management. Lead the transition and integration of CAPA processes to meet evolving regulatory requirements.
CAPA & Non-Conformance Management: Facilitate and lead the CAPA Review Board, ensuring robust problem definition, investigation, and effectiveness checks. Deliver training on CAPA and NC subsystems across the company. Mentor cross-functional owners in R&D, Manufacturing, and Supplier Quality on root cause analysis and investigation best practices.
Root Cause Analysis & Risk Management: Lead complex, high-risk investigations using RCA tools. Partner with the Quality Engineering team to ensure strong linkage between NC/CAPA investigations and the Risk Management File (ISO 14971), dynamically updating risk assessments based on observed failure modes.
Audit & Regulatory Support: Act as the SME for CAPA and NC during internal and external audits (FDA, Notified Body, MDSAP). Perform internal mock audits to identify gaps prior to external inspections.
Required Skills: Deep working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR. Proficiency in statistical tools (Tableau, Minitab) for trending and effectiveness verification. Strategic thinking to identify systemic risks. Ability to influence cross-functional teams without direct authority. Exceptional technical writing for audit-ready investigation summaries.
Education: Bachelor's degree in Biomedical, Mechanical, Industrial Engineering, or related Life Science discipline. Master's degree or advanced certification (ASQ CQE/CQA, Six Sigma Black Belt) preferred.
