Strategic Supplier Quality Engineer (Medical Devices)

Argon Medical Devices, Inc.; Athens (TX); On-site; USD 90,000 - 115,000; Full time

Job summary

Argon Medical Devices, Inc. is seeking a Supplier Quality Engineer to manage supplier relationships and oversee incoming inspection in our Plano, Texas facility and across related sites.

You will drive supplier performance, quality investigations, and process improvements in a regulated medical device environment. The role requires a BS in engineering and 3+ years in quality engineering with hands-on audits, GD&T interpretation, and data analysis.

Qualifications

• BS Degree in Engineering required.
• 3+ years of experience as a Quality Engineer required.
• Previous experience in FDA/ISO regulated industry required. SO 13485 Medical Device industry preferred
• CQE and CQA preferred.
• Ability to interpret engineering drawings, GD&T, and technical specifications required
• Hands-on experience with audits, inspections, and statistical analysis required

Responsibilities

• Manage supplier relationships and oversee the site’s incoming inspection processes.
• Improve incoming inspection process by refining process flow, utilizing existing equipment, and/or purchasing new equipment.
• Manage Dock-To-Stock (DTS) program based on supplier performance.
• Manage incoming AQL switching rules program.
• Provide supplier scorecards based on performance categories.
• Onboarding new suppliers and/or materials with cross functional collaboration.
• Issue/resolve nonconforming products through the SCAR/NCR process with suppliers.
• Work with suppliers on their changes through the supplier notification process (SNC) and be the representative for the Wheeling location.

Skills

Quality Engineering

Supplier Management

GD&T

Audits & Inspections

Statistical Analysis

FDA/ISO Regulations

Education

BS in Engineering

Job description

Argon Medical Devices, Inc. is seeking a Supplier Quality Engineer to manage supplier relationships and oversee incoming inspection in our Plano, Texas facility and across related sites.

You will drive supplier performance, quality investigations, and process improvements in a regulated medical device environment. The role requires a BS in engineering and 3+ years in quality engineering with hands-on audits, GD&T interpretation, and data analysis.