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Director, Design Quality - Infusion Systems

$176k - $242k

Baxter Healthcare

Round Lake, IL

Director of Design Quality will lead a team overseeing product development, lifecycle management, and post-market monitoring for Baxter's Infusion Systems portfolio. The role requires establishing quality strategies aligned with regulatory standards, driving continuous improvement, and serving as a subject matter expert across cross-functional teams.

Responsibilities

  • Lead design quality team responsible for product development and lifecycle management activities
  • Develop and implement design quality strategies aligned with company goals and regulatory requirements
  • Establish design quality metrics and key performance indicators; conduct regular reviews and analyses
  • Serve as subject matter expert providing guidance to cross-functional teams and external partners
  • Partner with quality system stewards to develop and improve quality system processes

Requirements

  • Bachelor's degree in engineering, science, or related field; advanced degree preferred
  • 10+ years in quality, engineering, or product development; 7+ years in managerial roles
  • Deep knowledge of medical device and combination product development cycles
  • Understanding of worldwide regulatory requirements and industry standards
  • Expertise in quality decision-making, risk management, and quality engineering
  • Strong conflict resolution and persuasive management skills

Compensation: $176,000-$242,000 base annually

Apply
Vacancy posted 25 days ago
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