Supplier Quality Engineer
Bio-Techne
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.
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