Quality Program Manager
Core
Integrating CathWorks quality systems and processes into Medtronic's global quality framework to ensure regulatory compliance and process harmonization.
Role type
Quality Program Manager (Medical Device Integration)
Builds
Global quality framework alignment for digital health technologies
Domain
Medical Device / Digital Health / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS integration, Design Controls, CAPA management, Complaints handling, Software validation, Regulatory compliance (FDA/MDR/ISO), Project management, Risk mitigation
Preferred skills
Large-scale QMS harmonization, Electronic QMS platforms, Software Design Controls
Technologies
FDA regulations, MDR, ISO 13485, 21 CFR Part 11
Responsibilities
Lead mapping and migration of quality processes, Oversee CAPA and complaints management, Provide oversight of software development lifecycle, Ensure compliance with regulatory requirements, Facilitate stakeholder engagement and continuous improvement
Seniority
Senior, hands-on IC
