Senior Device Quality Engineering Lead
Core
Lead quality engineering oversight for design control, risk management, and lifecycle activities for medical devices and combination products.
Role type
Senior Device Quality Engineering Lead
Builds
Robust product realization and regulatory-compliant medical devices
Domain
Medical device industry / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control expertise, Risk management expertise, Regulatory requirements knowledge, Quality standards knowledge, Cross-functional team leadership, Continuous improvement leadership, Supplier and testing partner management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead quality engineering guidance and oversight for medical devices and combination products during feasibility, design control, risk management, and lifecycle management; Define critical quality characteristics for device components and finished devices; Support internal and external audits as a Subject Matter Expert; Oversee the quality review and approval of technical documentation; Provide input to process manufacturing design and design transfer; Lead continuous improvement initiatives for the Quality Management System; Manage quality assurance interfaces with medical device suppliers and testing partners
Seniority
Senior, Management level
