Senior Manager, QMS
Core
Establish, implement, and maintain the enterprise Quality Management System (QMS) across all manufacturing and operational facilities to ensure compliance, drive continuous improvement, and support rapid business growth.
Role type
Senior Manager, Quality Management System (QMS)
Builds
Enterprise QMS framework, quality operating system, compliance controls, and quality data integration
Domain
Manufacturing / Quality Engineering / Industrial Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure (QMS systems & processes)
Required skills
ISO 9001 standards expertise, audit program leadership, CAPA/NCR governance, root cause analysis (8D, 5-Why, Fishbone), document and change control, quality metrics analysis, cross-functional leadership, risk-based quality management, Lean Six Sigma
Preferred skills
ASQ CQA/CQE/CMQ/OE certification, Lean Six Sigma Green/Black Belt, enterprise QMS software implementation (MasterControl, ETQ, Veeva), greenfield site expansion, AI/predictive analytics in quality
Technologies
ERP, MES, inspection tools, enterprise QMS software platforms
Responsibilities
Own and maintain the overall QMS framework and governance mechanisms; Direct the enterprise audit program (internal, customer, supplier, regulatory); Govern CAPA/NCR workflows and standardize root-cause analysis; Manage quality document control and change-control processes; Establish quality record data governance and integrate with ERP/MES; Lead periodic Quality Management Reviews with executive leadership; Define role-based QMS training requirements and competency records; Lead Lean Six Sigma projects for continuous improvement; Institute risk-based QMS governance and maintain quality risk registers; Lead QMS readiness activities for new greenfield manufacturing sites; Partner with cross-functional teams to drive systemic issue resolution.
Seniority
Senior Manager, hands-on IC with strategic oversight
