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Medical Device Quality Manager

AbbVie · Waco, TX

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Role summary

AbbVie seeks a Quality Manager to oversee quality compliance for medical devices and combination products including breast implants, ocular devices, and infusion pumps. The role requires ensuring regulatory adherence, managing quality metrics, leading cross-functional teams, and coordinating with internal and external manufacturing partners.

What they're looking for

  • Bachelor's degree in life science or related technical field; graduate degree preferred
  • Minimum 7+ years quality assurance, regulatory, operations, or technical support experience
  • Strong quality assurance, manufacturing, laboratory, regulatory, or validation background
  • Analytical and problem-solving skills with ability to manage multiple complex tasks
  • Experience managing third-party external manufacturing relationships
  • Ability to navigate cultural and language differences in global environments

What you'll be doing

  • Oversee quality and compliance for assigned combination products and medical devices across multiple manufacturing environments
  • Lead quality metrics collection, verification, and improvement for management review and compliance assessment
  • Direct team of subject matter experts on product transfers, investigations, and quality deliverables
  • Coordinate audits, due diligence activities, and pre-approval inspection readiness with contract manufacturers
  • Conduct product quality investigations, root cause analysis, and corrective and preventive action management

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