Senior Quality Engineer

Company Overview

Argon Medical 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 compasses 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 Sr. Quality Engineer is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

What You Will Do

Design Controls & Risk Management

• Lead and maintain Design Control deliverables: Design & Development Plans, Design Inputs/Outputs, Design Reviews, Traceability Matrix, DHF updates, and DMR readiness.
• Own and facilitate ISO 14971 risk management: hazard identification, risk analyses (FMEA, dFMEA/pFMEA), risk controls, and risk-benefit rationale; ensure linkage to verification/validation and post-market surveillance signals.
• Define, review, and approve verification & validation (V&V) protocols and reports (including usability, biocompatibility, sterilization, packaging validation, shelf life, transportation, and software validation as applicable).

Test Methods, Measurement & Data Integrity

• Develop, validate, and transfer test methods (TMV/MSA: accuracy, precision, repeatability/reproducibility, linearity, bias, gage R&R).
• Establish acceptance criteria using sound statistics (e.g., tolerance intervals, confidence levels, sample size determination, DOE when appropriate).
• Ensure data integrity (ALCOA+) and compliant documentation in eQMS/PLM systems.

Design Transfer & Process Readiness

• Partner with Manufacturing Engineering on process characterization (IQ/OQ/PQ), CTQ definition, control plans, and inspection methods.
• Approve FAI for critical components; ensure supplier controls and incoming inspection are aligned to risk.
• Lead line readiness for pilot builds and PP events; facilitate defect prevention (Poka‑Yoke, SPC implementation, mistake-proofing).

Regulatory & Standards Compliance

• Ensure compliance with 21 CFR 820, ISO 13485, MDSAP, ISO 14971, and applicable standards (IEC 60601, ISO 10993, ISO 11135/11137, ISO 11607, IEC 62366, IEC 62304 for software, etc.).
• Provide quality input to regulatory submissions (510(k), PMA, EU Technical File) including verification summaries, risk files, and labeling controls.

Problem Solving & CAPA

• Drive root cause analysis (5‑Why, Ishikawa, Fault Tree) and implement CAPA with effectiveness checks.
• Lead defect prevention and continuous improvement using Lean/Six Sigma tools (DMAIC, Kaizen, DOE).

Skills For Success

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

Physical Demands & Travel Required

• Light
• 5-10% Travel