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.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Position Overview::

The Quality Engineer is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

What you will do::

• Lead in the completion and maintenance of risk analysis and complaint evaluations.
• Lead the investigation, resolution and prevention of product and process nonconformance.
• Conduct internal audits as assigned and support customer audits for assigned product lines.
• 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.
• Lead in the Implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Lead, coach, and mentor non-exempt and entry level exempt personnel.
• Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues Design and conduct experiments for process optimization and/or improvement.
• Appropriately document experiment plans and results, including protocol writing and reports.
• 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) Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
• Work with design engineering in the completion of product verification and validation.
• 5-10% travel

Skills for Success::

• BS Degree and 3+ years as a Quality Engineer required in the Medical Device field required.
• Previous experience in FDA/ISO regulated industry required.
• CQE and CQA preferred.