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.