Senior CAPA Engineer

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. Argons 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

Position Overview::

The Senior CAPA Engineer is responsible for strategic leadership, execution, and continuous improvement of the Corrective and Preventive Action (CAPA) system. This role ensures compliance with FDA 21 CFR 820, ISO 13485, and internal quality system requirements. The Senior CAPA Engineer leads complex investigations, mentors quality personnel, and drives systemic improvements across products, processes, and quality systems to ensure sustained compliance and product safety.

What you will do::

• Serve as system owner for the CAPA process in compliance with FDA 21 CFR 820.100 and ISO 13485:2016 Clause 8.5.2 and 8.5.3.
• Lead and approve complex CAPA investigations including audit findings, nonconformances, complaints, and process failures.
• Ensure appropriate root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
• Develop, implement, and monitor corrective and preventive actions that address both immediate and systemic issues.
• Define, execute, and document CAPA effectiveness checks to confirm long-term resolution.
• Ensure timely CAPA progression, documentation integrity, and compliance within the Quality Management System (QMS).
• Analyze quality metrics and trends to identify recurring and potential systemic issues.
• Link CAPA activities with risk management, complaint handling, audit outcomes, and management review.
• Provide subject matter expertise during FDA, Notified Body, and customer audits, including CAPA responses and follow-up.
• Mentor and coach Quality Engineers and cross-functional teams on CAPA and problem-solving best practices.
• Drive continuous improvement initiatives aligned with Lean and Six Sigma methodologies.
• Participate on cross-functional teams and represent the Quality function as a senior contributor.

Skills for Success::

• Bachelors degree in Engineering, Science, or related field
• 7+ years of experience in Quality Engineering within an FDA- and ISO-regulated environment

• Expert knowledge of FDA QSR (21 CFR 820) and ISO 13485 requirements

  Advanced root cause analysis and risk-based decision-making

• Demonstrated experience leading CAPA systems and regulatory audit engagements

Preferred Qualifications

• Certified Quality Engineer (CQE)
• Certified Quality Auditor (CQA)
• Certified Project Management

Physical Demands & Travel

• Light physical demands
• 510% travel