Sr Manager QA Engineering
Core
Leading Quality Engineering teams to develop, qualify, and validate high-volume manufacturing automation equipment for continuous glucose monitoring (CGM) devices.
Role type
Senior Manager, Quality Engineering (Manufacturing Automation)
Builds
High-volume manufacturing automation equipment and validated processes for CGM devices
Domain
Medical Devices / Continuous Glucose Monitoring / Manufacturing Automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA 21 CFR 820, ISO 13485, Design Controls, Process Validation, Risk Management, Quality Management Systems, Team Leadership, Budget Management, Cross-functional Partnership
Preferred skills
Organizational Development, Strategic Planning, Regulatory Inspection Readiness, Continuous Improvement, Resource Allocation
Technologies
Manufacturing Automation Equipment, Quality Management Systems (QMS)
Responsibilities
Lead and develop Quality Engineering teams for equipment qualification and process validation; Establish strategic direction for quality activities aligned with regulatory and business goals; Partner with Engineering and Operations to mitigate quality and compliance risks; Drive continuous improvement through metrics, CAPA, and systemic problem-solving; Represent Quality Engineering in internal, customer, and regulatory audits; Manage departmental priorities, resources, and budgets.
Seniority
Senior Manager, hands-on leadership with strategic oversight