Engineering Program Manager/QCTM - ENT - Jacksonville, FL (Onsite)
Core
Engineering Program Manager serving as Quality Core Team Member (QCTM) to drive quality, reliability, and compliance strategy across the product lifecycle for medical devices.
Role type
Senior IC Engineering Program Manager (Quality)
Builds
Medical device products from concept through commercialization and post-market transition
Domain
Healthcare / Medical Devices / Quality Engineering
Required skills
Cross-functional program leadership, Quality systems (Design/Supplier/Manufacturing/Software), Risk management, Regulatory compliance, Root cause analysis, Supplier and manufacturing partnership
Preferred skills
PMP certification, DRM/FTQ certifications, FDA 21 CFR Part 11/820, ISO 13485/14971/62304 knowledge, Medical device software lifecycle experience
Technologies
FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304
Responsibilities
Lead quality and reliability strategy, metrics, and risk management for NPD programs; Manage execution across extended quality functions; Represent Voice of Quality on cross-functional teams; Drive Design Reliability and Manufacturability (DRM) and defect prevention; Identify risks and lead root cause investigations; Partner with suppliers and manufacturing sites; Lead compliance planning and audit support.
Seniority
Senior, hands-on IC