Device Quality Senior Manager
Core
Support quality system integration and ensure compliance with global medical device and combination product regulations for AbbVie.
Role type
Senior Manager, Quality Assurance
Builds
Quality assurance policies, procedures, and integrated quality systems for medical devices and combination products.
Domain
Medical Devices / Combination Products / Regulatory Compliance
Required skills
Quality system oversight, Design control, Cross-functional team leadership, Project management, Regulatory knowledge (ISO, US CFR, EU), Conflict resolution
Preferred skills
Device regulation experience, Regulatory agency interface experience
Technologies
ISO standards, US Code of Federal Regulations, EU regulations
Responsibilities
Develop and implement quality assurance policies and procedures; Manage interrelated function activities including design control and supply chain coordination; Support new product introduction and design changes; Oversee training for revised quality system policies; Represent the company in external industry groups.
Seniority
Senior, hands-on IC with leadership responsibilities