Quality Compliance Program Manager
Core
Lead global quality and compliance strategies, audit readiness, and risk reduction for the Electrophysiology division's medical device manufacturing.
Role type
Senior IC Quality Compliance Program Manager
Builds
Global quality programs, audit readiness plans, and compliance governance frameworks for medical device manufacturing.
Domain
Healthcare / Medical Devices / Quality Management Systems
Required skills
Strategic program leadership, cross-functional partnership, audit lifecycle management, regulatory change management, risk mitigation, executive reporting, data integrity, continuous improvement, stakeholder influence, budget management
Preferred skills
Medical device industry experience, FDA/Notified Body audit support, MDSAP/ISO standards knowledge, international operations, foreign language proficiency, business acumen
Technologies
Quality Management Systems (QMS), analytics tools, automation platforms
Responsibilities
Develop and execute global quality/compliance strategies; lead external audit lifecycle and inspection readiness; manage regulatory change and certificate activities; drive continuous improvement and risk reduction; support field actions and quality events; mentor colleagues on compliance best practices
Seniority
Senior, hands-on IC with strategic leadership