Medical Device Quality Manager
Core
Ensures quality and compliance of combination products and medical devices (breast implants, ocular implants, infusion pumps) across AbbVie plants and third-party manufacturers.
Role type
Senior Quality Assurance Operations Manager
Builds
On-market support for medical devices and combination products
Domain
Medical Devices / Life Sciences
Required skills
Quality Assurance Operations Management, Regulatory Compliance, Third-party Manufacturing Oversight, Root Cause Analysis, Corrective and Preventive Actions (CAPA), Audit Management, Strategic Planning, Crisis Management, Cross-functional Leadership
Preferred skills
Graduate degree, Technical or Analytical background, Experience with contract manufacturing
Technologies
None stated
Responsibilities
Develop regulatory strategies for product brands, lead quality metrics collection and improvement, manage team of SMEs for project activities, negotiate with external quality organizations, lead audit plans and inspection readiness, participate in product quality investigations, coordinate complaint trend investigations
Seniority
Senior, hands-on IC with leadership responsibilities
