Supplier Quality Engineer

Role: Supplier Quality Engineer responsible for ensuring quality, reliability, and regulatory compliance of materials in manufacturing and supply chain operations within a regulated environment. Responsibilities: qualify and onboard suppliers, manage supplier performance, conduct audits (ISO 13485, ISO 9001, FDA), lead corrective actions, support CAPA, investigate nonconformities, and collaborate on process improvements. Qualifications: Bachelor's in Engineering or related field; 2-5 years in Supplier Quality or Quality Engineering, ideally in Medical Device, IVD, biotech, or pharma manufacturing; strong analytical, problem-solving, communication skills; ASQ CQE, CSQP, Six Sigma Green Belt preferred; auditor experience plus knowledge of PPAP, FMEA, SPC, cGMP, ISO 13485, FDA standards. High-Value: regulated manufacturing, supplier qualification, CAPA, audit leadership, biotech/pharma focus. Work setup: onsite in a laboratory/production environment; physical ability to handle materials and perform extensive computer work; standard hours with occasional variation.