Hiring: Director - Post Market Quality Company: Heartflow Location: Austin, TX Job Posted Time: 2026-09-10 11:19:52 Target Skills & Keywords : Product Management, R, Risk Management, Root Cause Analysis About the job Experience: •13+ years of progressive experience in Quality within the medical device industry, with at least 7+ years in a leadership/management role. •Expert-level knowledge of relevant regulations and standards, including 21 CFR Parts 803 and 806, the FDA Quality Management System Regulation, EU MDR, ISO 13485, and ISO 14971. •Demonstrated ownership of MDR and vigilance reporting decisions. •Demonstrated success in successfully leading or playing a key SME role in regulatory inspections (FDA, Notified Body). Required Skills: •Working through the Manager of Complaint Handling, direct the designated complaint handling unit, ensuring intake, triage, documentation, investigation, and closure satisfy ISO 13485:2016, the FDA Quality Management System Regulation (21 CFR Part 820, as amended), and EU MDR requirements. •Own complaint handling processes, procedures, and decision criteria, ensuring every complaint carries a robust documented reportability decision and a defensible closure rationale in the record. •Approve closure of high-severity complaint files, including event coding to IMDRF adverse event terminology, and ensure coding is applied consistently enough to support credible and robust trending. •Manage complaint cycle time against defined service levels, escalating aged, high-severity, or patient-impacting cases to the Executive Leadership Team. •Ensure customer-facing investigation responses are technically accurate, consistent with the underlying investigation record, and insightful to the customers. •Utilize emerging AI tools to incorporate improved quality, consistency, and efficiency within the complaint handling process and incorporate proactive monitoring of SaMD algorithm performance in the field. •Lead the Product Investigations (PI) function through the Manager of PI, ensuring root cause analysis is evidence-based, proportionate to risk, and traceable from the reported symptom through to disposition for robust trend analysis. •Route confirmed product issues into CAPA, risk management file updates, and other non-conformance and corrective action subsystems. Qualifications: •Direct experience with AI/ML-driven SaMD and cloud-based medical device platforms. •A reasonable estimate of the base salary compensation range is $180,000 to $225,000 per year, cash bonus, and equity. •Bachelor's degree in engineering or scientific discipline, or equivalent. Compensation: •$180,000 - $225,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!