Senior Manager Quality Compliance
Core
Lead quality system compliance initiatives, audit readiness, regulatory change management, and field actions for the Electrophysiology business.
Role type
Senior Manager, Quality Compliance
Builds
Compliance strategies, audit readiness programs, and global quality management systems for medical device division
Domain
Healthcare / Medical Devices / Quality Management Systems
Required skills
Quality Management Systems, regulatory compliance, audit management, risk assessment, stakeholder influence, program leadership, cross-functional collaboration, strategic planning, data analysis, change management
Preferred skills
FDA inspection support, Notified Body audits, MDSAP, ISO standards, international operations, foreign language proficiency, business acumen
Technologies
Quality Management Systems, regulatory databases, analytics tools
Responsibilities
Lead external audit lifecycle and inspection readiness; Develop and execute global compliance strategies; Manage Health Hazard Evaluation and field action programs; Mentor team members and drive continuous improvement; Coordinate cross-functional partnerships for quality governance; Monitor quality metrics and compliance trends
Seniority
Senior, hands-on IC with management responsibilities