Principal Device Quality Engineer

Heartflow is seeking a seasoned Principal Quality Engineer to own the CAPA system and lead as the Subject Matter Expert (SME) and process owner for the process Non-Conformance (NC) and Corrective and Preventive Action (CAPA) subsystems. This is a strategic, high-visibility role is responsible for not only acting as process owner but also executing complex investigations, lead CAPA reviewer and process oversight, and continuous improvement of these critical processes. 

You will lead cross-functional teams in facilitating CAPA Boards, Root Cause Analysis teams, monitoring KPIs and driving systemic improvements to ensure our products meet the highest standards of safety and efficacy while maintaining process compliance with FDA, ISO, and EU MDR requirements.

Job Responsibilities:

Process Ownership & Strategy

• Serve as the Global Process Owner for CAPA subsystem ensuring the actions and records are robust, effective, and compliant.
• Monitor the health of the CAPA and NC subsystem through the development and analysis of Key Performance Indicators (KPIs) and quality dashboards.  Communicate necessary measures to CAPA owners and management.
• Lead the transition and integration of CAPA processes to meet evolving regulatory focus areas.

CAPA & Non-Conformance Management

• Facilitate and lead the Corrective and Preventive Action (CAPA) Review Board, ensuring robust problem definition, investigation, and effectiveness checks.
• Deliver training on the CAPA and NC subsystem to ensure procedural requirements and best practices are known throughout the company.
• Mentor cross-functional owners (R&D, Manufacturing, Supplier Quality) on root cause analysis, investigation best practices to ensure actions are effective and documentation is robust and stands up to regulatory scrutiny.

Root Cause Analysis (RCA) & Risk Management

• Lead complex, high-risk investigations using RCA tools.
• Partner with QE team to ensure strong linkage between NC/CAPA investigations and the Risk Management File (ISO 14971), ensuring risk assessments are updated dynamically based on failure modes observed.

Audit & Regulatory Support

• Act as the SME for CAPA and NC during internal audits and external audits (FDA, Notified Body, MDSAP).
• Perform internal mock audits of the QMS subsystems to identify gaps prior to external inspections.

Skills Needed:

• Regulatory Mastery: Deep working knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 (Risk Management), and EU MDR.
• Statistical Competence: Proficiency in tools (e.g. Tableau, Minitab) for trending data and verifying effectiveness checks.
• Strategic Thinking: Ability to look beyond a single non-conformance to identify systemic risks across the processes and organization.
• Influence without Authority: Proven ability to drive results and enforce quality standards with cross-functional teams (R&D, Clinical, Quality) without direct reporting lines.
• Technical Writing: Exceptional ability to write clear, concise, and technically accurate investigation summaries that "tell the story" to an auditor.

Educational Requirements & Work Experience: 

Education:

• Required: Bachelor’s degree in Engineering (Biomedical, Mechanical, Industrial) or a related Life Science discipline.
• Preferred: Master’s degree or Advanced Certification (e.g., ASQ CQE, CQA, Six Sigma Black Belt).

Experience:

• 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.

Travel up to 15%

A reasonable estimate of the base salary compensation range is $150,858 to $155,000 per year, cash bonus, and equity.