Senior Supplier Quality Engineer

Argon Medical Devices, Inc.; Town of Texas (WI); On-site; USD 85,000 - 115,000; Full time

Job summary

A leading company in the medical devices sector seeks a Senior Supplier Quality Engineer to enhance quality management systems and lead process improvements. The role involves risk analysis, supplier evaluation, and ensuring compliance with FDA/ISO standards, requiring a combination of technical expertise and leadership skills.

Qualifications

• 8 years of experience as a Quality Engineer required.
• Previous experience in FDA/ISO regulated industry required.
• CQE and CQA preferred.

Responsibilities

• Lead risk analysis and FMEAs.
• Support complaint evaluations and supplier assessments.
• Conduct internal process audits and lead investigations of nonconformance.

Skills

Risk analysis

Root cause analysis

CAPA investigations

Project Management

Process optimization

Education

BS degree in science/technical field

Job description

Company Overview:

Argon Medical Devices 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

Outstanding opportunity to join our team in Athens, TX!

Position Overview:

The Senior Supplier Quality Engineer is responsible for developing and maintaining quality management systems of the site along with providing support for new product development, manufacturing, and system/services.

What you will do:

• Lead in the completion and maintenance of risk analysis and FMEAs (pFMEA & dFMEA).
• Ability to make risk-based decisions and operating in the gray.
• Support complaint evaluations and assist with the implementation of improvement initiatives.
• Support supplier evaluations and maintenance of approved supplier list.
• Lead the investigation, resolution and prevention of product and process nonconformance.
• Conduct internal process audits as assigned and support customer audits for assigned product areas.
• 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.
• Utilize root cause analysis and CAPA investigations to prevent reoccurrence along with implementation of the suggestion solution.
• Lead, coach, and mentor production and quality 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.
• 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.
• 10-20% travel

Skills for Success:

• BS degree required; science/technical field preferred.
• 8 years of experience as a Quality Engineer required.
• Previous experience in FDA/ISO regulated industry required.
  • ISO 13485 medical device industry preferred.
• CQE and CQA preferred
• Project Management