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Supplier Quality Engineer

3 months ago

Oklahoma City, United States BioTalent Full time

Introduction We are working with a medical equipment manufacturer seeking a

Supplier Quality Engineer

to join their team. Their product line focuses on small-scale surgical tools for specific procedures. You will be responsible for supporting the quality system and supplier/incoming quality.

This role will offer you Working with class III technology assisting with life-saving surgical procedures. Tenured company history of unique product - market frontrunner for product line. Annual Bonus + 401(k).

You will be responsible for Work with suppliers and the Purchasing department to address quality issues with raw materials and components. Make use of statistical techniques, risk analysis, Gage R&R, etc. Solve problems using Cause & Effect diagrams, FMEA, Root Cause Analysis, etc. Perform Corrective Actions and Non-conformance assessments. Perform supplier audits as well as internal audits. Support Incoming Inspection. Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends. Participate in and lead continual improvement projects. Travel up to 25% required.

You will bring the following 3-5 years in a relevant position + BS in an engineering capacity. Experience in regulated, relevant environments (FDA 21 CFR Part 820, ISO 13485, ISO 14971, etc.). At least 5 years of experience working with suppliers in the medical device is preferred. Experience with supplier audits and supplier management. Lean manufacturing and 6-Sigma certification is a plus.

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