Associate Manager, Quality Systems
Core
Lead a team to maintain and improve quality processes, ensuring regulatory compliance and patient safety for medical devices.
Role type
Senior IC quality systems manager
Builds
Quality management systems and compliance frameworks for medical devices
Domain
Medical devices / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team leadership and coaching, Corrective and preventive action (CAPA) management, Document control, Change management, Audit coordination and readiness, Nonconformance investigation and resolution, Quality system training program development, Process improvement and trend analysis
Preferred skills
Master's degree or PhD, Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma certification, Medical Device Single Audit Program (MDSAP) knowledge
Technologies
ISO 13485, FDA regulations
Responsibilities
Lead and develop a team of Quality Systems professionals, Manage quality system processes including CAPA and document control, Ensure compliance with ISO 13485 and FDA regulations, Coordinate internal and external audits, Partner with cross-functional teams to investigate quality issues, Oversee resolution of nonconformances, Deliver and maintain quality systems training programs
Seniority
Senior, hands-on IC