Quality Manager
Core
Developing, establishing, and maintaining quality assurance programs, policies, processes, and controls to ensure product performance and quality conform to established standards and agency regulations for medical devices.
Role type
Senior IC Quality Manager (Medical Device Development)
Builds
Drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters, software, vessel closure devices, and peripheral stents.
Domain
Healthcare / Medical Devices / Vascular
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Engineering leadership, Design Control, Test Method Validation, Risk Management, Project Management, People Leadership, Nonconformance Management, Six Sigma, Lean, Cross-functional team leadership, Regulatory compliance (US 21 CFR 820, ISO 13485), ATE support, Validation of NPS tools
Preferred skills
Six Sigma Black Belt, ASQ Certified Quality Engineer, Advanced degree, Experience in broader enterprise/cross division business unit model
Technologies
US 21 CFR 820 (QSR), ISO 13485, ATE, NPS tools
Responsibilities
Provide Quality Engineering leadership in direct support of medical device development, Manage and influence development of Quality Engineers and Technicians, Define and implement critical parameters for design control, Lead cross-functional teams to complete quality initiatives, Oversee Nonconformance and Real-time data management portions of the quality system, Manage activities of the Post-Production Quality Engineering team, Support ATE at all stages of development process, Maintain effective Quality Metrics and execute activities to resolve decreases in performance
Seniority
Senior, hands-on IC
