Senior Supplier Quality Engineer

Overview

Resonetics Hutchinson is looking for a Senior Supplier Quality Engineer to join the team! The Supplier Quality Engineer provides supplier-facing quality support for contract manufacturing of medical device components. 

 

You will manage supplier quality activities including performance evaluation and metric reporting, conduct supplier audits and qualifications, as well as product quality engineering activities.

 

We are lookin for someone who has experience using Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, reducing dependence on inspection, ISO compliance.

Responsibilities

• Managing supplier quality and performance.
• Assessing and determining sources of raw materials and services to support product development and production.
• Approving supplier qualifications and classifications.
• Developing and administering supplier quality agreements.
• Collecting and monitoring supplier quality performance data.
• Liaising with customer quality personnel to resolve issues and Customer Complaints.
• Issue and manage Supplier Corrective Actions through completion.
• Assisting with troubleshooting of production and PDP processes.
• Developing and maintaining quality/control plans for incoming materials.
• Developing Quality Procedures and conduct personnel training on Quality Procedures.
• Approving Nonconformance disposition.
• Working on continual improvement and process assessment projects as assigned.

Qualifications

• Minimum 5 years’ experience in a Supplier Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent experience.
• Demonstrated technical writing and communication skills.
• Working knowledge of Statistical software and/or Minitab.
• Bachelor’s degree or equivalent experience.
• Knowledge of ISO 13485