Senior Quality Engineer

Company Overview

Argon Medical 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.

The Sr. Quality Engineer will be required to successfully implement Lean/TPS principles in several manufacturing operations, maintain and direct process validation efforts to aid in seamless & cost‑effective delivery of all products and services, while maximizing the utilization of all material and labor resources. This will include the integration of superior process reliability, resulting in the delivery of high‑quality products that exceed global medical device industry standards.

• Identify and implement effective process control systems to support the development, qualification, and on‑going manufacturing of products to meet or exceed internal and external requirements.
• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Assist or lead general compliance activities as required. Helps provide data for business case for recommended product improvements.
• Lead process control and monitoring of CTQ parameters and specifications. Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Design and conduct experiments for process optimization and/or improvement. Appropriately document experiment plans and results, including protocol writing and reports.
• Work with design engineering in the completion of product verification and validation.
• Analyze medical device reporting data to identify trends and notify designated internal personnel with the findings and recommendations. Enables rapid and effective escalation and investigation of potential safety‑related issues.
• Appropriately document experiment plans and results, including protocol writing and reports.

• Bachelor’s degree required.
• 8+ years of demonstrated Process Improvement Leadership in a manufacturing environment.
• 3+ years working in a regulated (ISO 13485 or ISO 9001) environment. Medical Device experience with machining, grinding, and extrusion work approaches preferred.
• Hands‑on experience with Lean/Six Sigma tools such as value‑stream mapping, fish bone diagrams, pareto diagrams, 5S, Kanban, Standard Work.
• Demonstrated success in establishing a Process Improvement Culture that results in improvements in Safety, Quality, Delivery, and Cost.
• Familiarity with considerations and terminology of health care and/or medical device industry.
• Thorough knowledge of Quality, Regulatory Compliance, and operations systems and processes, including GMP, GCP and QSR requirements for medical devices.
• Minitab software or similar statistical analysis software tool;
  General Microsoft Office applications.