Senior Quality Engineer (Medical Devices)

Location: Athens, Texas, United States; onsite role with 5–10% travel

Company

hirify.global manufactures specialty medical products for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology.

What you will do

• Lead design control deliverables, including development plans, design inputs and outputs, design reviews, traceability, DHF updates, and DMR readiness.
• Own ISO 14971 risk management activities, including hazard identification, FMEA, risk controls, and risk-benefit analysis.
• Define, review, and approve verification and validation protocols and reports across usability, biocompatibility, sterilization, packaging, shelf life, transportation, and software validation.
• Develop, validate, and transfer test methods; establish statistically sound acceptance criteria and maintain data integrity in eQMS and PLM systems.
• Partner with Manufacturing Engineering on process characterization, critical-to-quality definitions, control plans, inspection methods, pilot builds, and production readiness.
• Lead root cause analysis, CAPA, defect prevention, and continuous improvement initiatives.

Requirements

• BS degree required.
• 8+ years of Quality Engineer experience required.
• Previous experience in an FDA- and ISO-regulated industry required.
• Experience with 21 CFR 820, ISO 13485, MDSAP, ISO 14971, and applicable medical device standards.
• Knowledge of FMEA, statistical methods, IQ/OQ/PQ, SPC, Lean, and Six Sigma tools.

Nice to have

• CQE certification.
• CQA certification.

Culture & Benefits

• Work is based onsite in Athens, Texas.
• Travel requirement of 5–10%.
• Role supports products intended to improve patient outcomes through image-guided procedures.