Quality Systems and Compliance Lead

Drives quality excellence at Verily by owning one or more Quality Assurance domains and leading strategic QA initiatives Responsible for designing and advancing robust quality systems Ensures that products are developed, commercialized, and sustained to the highest standards of quality Analyzes quality metrics and performance data to identify trends and implement effective corrective actions Partners with engineering and product teams to embed quality practices into development workflows Requirements Bachelor's degree in a scientific, engineering, or related field 8+ years of experience in quality assurance or regulatory affairs within the medical device, digital health, or life sciences industry Demonstrated experience leading or managing a QMS in conformance with ISO 13485:2016 and FDA QMSR Experience supporting or managing quality across SaMD and/or AI/ML-enabled products Proven ability to lead cross-functional quality initiatives Core Competencies Demonstrates expertise in Quality Assurance and Quality Management Systems (QMS) within the medical device and life sciences sectors, with a strong focus on ISO 13485:2016 compliance and FDA regulations. Proven ability to lead cross-functional teams and implement quality initiatives that enhance product development and commercialization. Highest-signal resume keywords Quality Management System (QMS) Leadership ISO 13485:2016 Compliance FDA QMSR Knowledge Cross-Functional Team Leadership SaMD and AI/ML Product Quality Assurance ATS Optimization Keywords Hard Skills Hard Skills Quality Assurance Quality Metrics Analysis Corrective Action Implementation Quality System Design Regulatory Affairs Soft Skills Strategic Leadership Collaboration Analytical Thinking Industry Keywords Medical Device Digital Health Life Sciences Quality Excellence Product Development #J-18808-Ljbffr Jobtailor