Supplier Quality Engineer

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

Company Overview

Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Position Overview

We are looking for a motivated Supplier Quality Engineer to join our quality team. In this role, you will be managing our supplier relationships, performance, and assist with investigations until resolved. You will work to improve the site’s incoming inspection capabilities including inspection methods, sampling plans, and approved supplier/materials list. You’ll work closely with subject matter experts within the quality, manufacturing, engineering and procurement departments to improve product quality and schedule adherence.

What you will do

The supplier quality engineer will be responsible for managing the supplier relationships and overseeing the sites incoming inspection processes. The key responsibilities are outlined below:

• Supplier Management
• Issue/resolve nonconforming products through the SCAR/NCR process with suppliers.
• Provide supplier scorecards based on performance categories
• Work with suppliers on their changes through the supplier notification process (SNC) and be the representative for the Wheeling location.
• Onboarding new suppliers and/or materials with cross functional collaboration

• Incoming Inspection
• 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.

Skills for Success

• 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