Sr. Quality Engineer
- Job Title
- Sr. Quality Engineer
- Job ID
- Athens, TX
- Other Location
Senior Quality Engineer, Athens, TX.
We’re hiring for a Senior Quality Engineer to join our QC/RA Department at our Athens, TX facility.
Job Description: The Senior Quality Engineer will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support teams. This individual will work to 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. It will be the responsibility of this role to lead the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
The Sr. Quality Engineer will assist in the development and execution of streamlined business systems issues applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. This individual will design and conduct experiments for process optimization and improvements, ensuring that appropriate document experiment plans and results, including protocol writing and reports, are added to Argon’s EQMS. Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Senior Quality/Regulatory Engineer Education and Experience Requirements:
- BS degree in Engineering or Technical Field or equivalent experience
- five years of experience as a Quality Engineer
- Experience with FMEA and Risk Assessment as they pertain to product development
- Engineering experience and demonstrated the use of Quality tools/methodologies
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
- 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
The Sr. Quality Engineer will manage process control and monitoring of CTQ parameters and specifications and will work to implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). This quality professional will work on and provide solutions to a wide range of difficult problems relating to the quality and/or regulatory aspects of design, validation, and manufacture of Class I and higher medical products. Serve as owner and administrator of several aspects of the quality system, including but not limited to supplier management, process control, statistical techniques, and design control
Argon Medical is a global manufacturer of specialty medical products, including a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology. With over 800 employees worldwide. Argon has manufacturing facilities located in Athens, TX, Wheeling, IL and Rochester, NY. Argon’s brand is recognized for best-in-class products that improve
patient outcomes via percutaneous, image-guided procedures. https://www.argonmedical.com/about/our-company.
- Required Skills
• BS degree in Engineering or Technical Field or equivalent experience
• five years of experience as a Quality Engineer
• Experience with FMEA and Risk Assessment as they pertain to product development
• Engineering experience and demonstrated the use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
• 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