Sr. Supplier Quality Engineer I
Core
Conducting and overseeing supplier audits, qualifying new suppliers, and monitoring supplier performance to assure conformance to standards and risk reduction for medical device components.
Role type
Senior Supplier Quality Engineer
Builds
Medical device components and assemblies (insulin pumps, control systems)
Domain
Medical device manufacturing / Quality Engineering
Required skills
Supplier audit management, CAPA plan generation, Quality Agreements creation, Supplier performance monitoring, Continuous improvement strategies, Statistical techniques (SPC, capability analysis), Problem-solving methodologies (5-why, FTA), GD&T interpretation, GMP principles, ISO standards knowledge (13485, 14971, 9001)
Preferred skills
ISO lead auditor certification, Certified Quality Engineer certification, PCB/PCBA/electro-mechanical assembly knowledge, Medical device/FDA-regulated industry experience, 3rd party contract manufacturer management
Technologies
ISO 13485, ISO 14971, ISO 9001, PFMECA, DMAIC, Lean, DOE, IQ/OQ/PQ validations
Responsibilities
Manage and lead supplier audits to meet company and regulatory requirements; Generate, approve, and monitor Supplier CAPA plans; Partner with stakeholders to create and revise Quality Agreements; Qualify and monitor supplier performance; Lead continuous improvement strategies for suppliers; Facilitate quality oversight of 3rd party contract manufacturers; Provide guidance on quality engineering disciplines and statistics; Report quality trends to management; Follow up on component non-conformances.
Seniority
Senior, hands-on IC
