Senior Supplier Quality Engineer

Overview

The Sr. Supplier Quality Engineer provides supplier-facing quality support for contract manufacturing of medical device components, sub-assemblies, and finished medical devices across the Resonetics organization. 

 

The Sr. Supplier Quality Engineer manages supplier quality activities including performance evaluation and metric reporting, conducts supplier audits and qualifications, as well as product quality engineering activities.

 

The Sr. Supplier Quality Engineer leads new supplier product launches and supplier change evaluations across the organization, as well as leads material compliance activities.

 

The Sr. Supplier Quality Engineer position uses 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

• Manage supplier quality program across the organization including selecting and reporting on program key performance indicators and critical supplier performance.
• Manage and lead the material declaration process for the organization.
• Issue and manage Supplier Corrective Actions through completion.
• Lead supplier qualifications and classifications.
• Develop and administer supplier quality agreements.
• Collecting and monitoring supplier quality performance data.
• Prepare and conduct Supplier Performance Reviews.
• Liaising with customer quality personnel to resolve issues and Customer Complaints.
• Generate process deviations and Customer Change Notice.
• Develop and maintaining quality/control plans.
• Developing PFMECAs.
• Resolving Corrective and Preventive Actions.
• Lead and manage the supplier audit program.
• Develop Quality Procedures and conduct personnel training on Quality Procedures.
• Approve Nonconformance Report dispositions
• Analyzing production data.
• Working on continual improvement and process assessment projects as assigned.

Qualifications

• Minimum 5 years’ experience in Supplier Quality Engineering 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