Senior Quality System Manager - NM - Rice Creek/Fridley, MN (Onsite)
Core
Strategic leadership for the Quality Management System (QMS) ensuring regulatory compliance, CAPA program oversight, and continuous improvement for neuromodulation therapies.
Role type
Senior Quality Systems Manager
Builds
Quality governance and compliance frameworks for spinal cord stimulation and deep brain stimulation devices
Domain
Medical device / Neuromodulation / Regulatory Quality
Deliverable
client delivery
Required skills
Quality Management System (QMS) strategy, CAPA program leadership, change control, management review, quality metrics analysis, audit support, cross-functional collaboration
Preferred skills
FDA QMSR and ISO 13485 expertise, root cause analysis, risk management, coaching and team leadership
Technologies
None stated
Responsibilities
Provide strategic and operational leadership for the QMS; Lead governance and oversight of the CAPA program; Oversee core quality system processes including change control and training; Monitor quality system performance and drive data-driven improvements; Partner cross-functionally to align quality processes with business objectives; Support internal and external audits and regulatory inspections
Seniority
Senior, hands-on IC with people management