Quality Engineer
Argon Medical Devices, Inc.
1445 Flat Creek Road
75751 Athens , TX
Job Description: 

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

Responsibilities Include: 
  • Complete and maintain risk analysis and failure evaluations Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
  • Lead the investigation, resolution and prevention of product and process nonconformances
  • Conduct internal audits as assigned and support customer audits for assigned product lines
  • Identify and implement effective process control and CAPA 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
  • 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
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
  • Other duties as assigned
  • BS degree plus 1 -2 years as Quality Engineer
  • Previous experience in FDA or ISO regulated industry preferred
  • CQE or CQA preferred
  • Strong skills in Microsoft Office especially Word and Excel; Visio and Minitab preferred

Must be able to read and write in English to follow SOPs and correspond with external customers