Unknown Company

Quality Systems and Compliance Lead

california, mo • Posted 1 weeks ago
Onsite Full Time Management & Operations

  • 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

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