Supplier Quality Engineer Consultant I
We are looking for a Supplier Quality Engineer for a role in Bothell, WA
This role will be providing support of our Supplier Quality Assurance Markets Team, focusing on finished Medical Device suppliers. Individual must hold a active certificates in ISO13485, ISO9001, and QSREG. The individual will be located in our Bothell, WA facility.
Individual will be responsible for Supplier Quality Performance Monitoring, assisting in the development of Quality processes relating to Supplier Quality Control's, works with the team to assist in supplier audits and supplier qualification, assessing supplier capabilities, supplier quality controls, audit and inspection experience, experience with supplier control.
Assure quality systems of OEMs, manufacturers and suppliers are maintained and acceptance criteria are in alignment with product use and customer expectations. Provide Quality oversight of product/process change requests from suppliers, ensuring appropriate regulatory review and adequate validation to support requested changes. Serve as internal and supplier quality auditor, managing planning, execution, reporting and closure of audits and audit findings.