Director, Medical Quality & Device Safety Risk Management Operations

Director of Medical Quality and Device Safety Risk Management Operations
Grade 22 | People Leader
Position Summary
Under the direction of the Head of Integrated Medical Quality and Device Safety, Global Patient Safety, the Director of Medical Quality and Device Safety Risk Management Operations leads a shared services group that connects Complaints Safety and Surveillance to product lifecycle risk management and issue escalation through Health Risk Assessment (HRA), serving as a trusted strategic partner, providing medical quality and device safety expertise to cross-enterprise stakeholders. The scope of responsibility spans the entire AbbVie portfolio, with emphasis on device lifecycle risk management.
Key Responsibilities
Drive strategy and best practices in safety contributions to product lifecycle risk management as cross-enterprise partner to Risk Management Center of Excellence and MDCP Quality Shared Services.
Facilitate and extend Integrated Medical Quality and Device Safety Physician contributions to quality and device risk management, including content development, documentation and maintenance.
Establish and maintain best practices in Health Risk Assessment in support of clinical supplies and post-market quality organizations, leading team of medical professionals and engineers as partners in performing HRAs.
Partner with Post-Market Quality Assurance in establishment and maintenance of medical concepts associated with complaint categories, mapping to and from device risk management documentation, informing terminology selection and reporting decisions.
Provide strategic and managerial oversight to embedded device terminology and coding subject matter experts, incorporating and leveraging mapping across the product lifecycle, as a partner to Complaints Safety and Surveillance.
Represent Medical Quality and Device Safety in audits and inspections.
Required Qualifications
Undergraduate and advanced degree in health sciences, such as Bachelor of Science in Nursing (BSN) AND Master of Science in Nursing (MSN), Nurse Practitioner (NP), Physician Assistant (PA). A Master of Public Health (MPH) may be considered.
Minimum 3 years of clinical experience.
Minimum 7 years of device safety experience that includes complaint assessment, device risk management, health risk assessment and field action support.
Demonstrated management and leadership.
Preferred Qualifications
Proven ability to influence cross-enterprise stakeholders.

Employment type
Full-time

Work arrangement
Hybrid