Manager, Quality Assurance
Core
Lead a dedicated Quality Operations team to drive preventative measures, continuous improvement, and compliance with regulatory standards for medical device manufacturing.
Role type
Senior IC Quality Manager (Operations)
Builds
Quality systems, compliance frameworks, and continuous improvement initiatives for medical device products
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team leadership, regulatory compliance management, audit program management, risk management, corrective action planning, strategic planning, cross-functional collaboration
Preferred skills
MBA, experience in automotive or regulated manufacturing
Technologies
None stated
Responsibilities
Lead a high-performing quality team providing technical guidance to operational areas; Ensure organizational conformance to customer requirements and regulatory standards; Drive compliance by defining quality standards with function managers; Manage product and patient risk and control deviations; Lead internal and external audits (Corporate, notified body, FDA); Develop quality improvement pipelines to reduce costs and inefficiencies; Monitor Quality KPIs and address adverse trends; Foster global collaboration on process improvement initiatives.
Seniority
Senior, hands-on IC
