Argon Medical Devices
Argon is a global manufacturer of specialty medical products. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Critical Care procedures . The Company's products are sold globally through a combination of direct sales representatives and premier distributors.
Senior Quality Engineer
Full-time
Argon Medical Devices
Argon
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. This position works out of our Athens, Texas manufacturing facility.

Responsibilities Include: 
  • 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 in the completion and maintenance of risk analysis and complaint evaluations
  • 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)
  • Lead the investigation, resolution and prevention of product and process non-conformances
  • Conduct internal audits as assigned and support customer audits for assigned product lines
  • 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
  • Other duties as assigned
Education/Experience: 
  • BS degree in Engineering or Technical Field or equivalent experience
  • 5+ years of experience as a Quality Engineer
  • Engineering experience and demonstrated use of Quality tools/methodologies
  • Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
  • Solid communication and interpersonal skills
  • Strong project and time management skills, including the demonstrated ability to work in multi-departmental project teams and resolve quality-related issues in a timely and effective manner

 

Special Skills/Abilities/Knoweledge: 
  • Strong Microsoft Office (Excel/Word/Access/Project/Visio) skills
  • ASQ CQE and CQA License/Certification Preferred
  • Previous experience with FDA/ISO 13485 regulated industry
Work Environment: 
  • Medical/Dental/Vision
  • FSA & Dependent Care
  • Company paid life insurance and AD&D
  • Supplemental Life
  • Company paid short-term and long-term disability
  • 401k Plan with employer contribution
  • Vacation/Personal/Holiday
  • Tuition Reimbursement Program