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

 

Responsibilities Include: 
  • Identify and implement effective process control systems to support the development, qualification, and ongoing 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 of 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.
  • 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 nonconformance.
  • Conduct internal audits as assigned and support 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.
  • Previous experience in FDA/ISO 13485 regulated industry
  • ASQ CQE and CQA preferred
  • Engineering experience and demonstrated use of Quality tools/methodologies.
Special Skills/Abilities/Knowledge: 
  • Strong Microsoft Office (Excel, Word, Access, Project, Visio) skills
  • 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.
  • Due to the business necessity of communication, safety and production, candidates must be able to speak, read and write English.