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
• 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.