Design Quality Assurance Manager
Core
Lead Design Quality Assurance activities and serve as the Quality representative on cross-functional product development teams to ensure compliance with Design Control requirements for implantable and extracorporeal blood pump systems.
Role type
Senior Design Quality Assurance Manager
Builds
CentriMag System and HeartMate 3 (implantable and extracorporeal blood pump systems)
Domain
Medical devices / Cardiovascular / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control, risk management, ISO 13485, 21 CFR part 820, EU MDD/MDR, MDSAP, people management, resource planning, stakeholder management
Preferred skills
Design for Six Sigma, Quality by Design
Technologies
ISO 13485, 21 CFR part 820, EU MDD/MDR, MDSAP
Responsibilities
Lead Design Quality Assurance activities throughout the product development lifecycle; Drive quality planning activities for new product development projects; Lead, coach, and develop Design Quality Engineers and other quality professionals; Establish team objectives, performance expectations, and development plans; Provide quality oversight for design changes and product enhancements; Promote a culture of quality, compliance, and continuous improvement.
Seniority
Senior, hands-on IC with leadership responsibilities
