Senior Quality Engineer

Argon Medical Devices Inc • Athens, TX

8d

About The Position

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.

Requirements

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

Nice To Haves

• CQE and CQA preferred.

Responsibilities

• 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).
• 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.
• 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).
• 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.
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior