Senior Quality Engineer (Medical Devices)

Location: Athens, Texas, United States. Onsite role with 5–10% travel.

Company

hirify.global Devices 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, including hazard identification, FMEA, risk controls, risk-benefit analysis, and links to verification, validation, and post-market surveillance.
• Define, review, and approve verification and validation protocols and reports covering applicable usability, biocompatibility, sterilization, packaging, shelf-life, transportation, and software activities.
• Develop, validate, and transfer test methods while establishing statistically sound acceptance criteria and ensuring ALCOA+ data integrity.
• Partner with Manufacturing Engineering on process characterization, CTQs, control plans, inspection methods, supplier controls, pilot builds, and production readiness.
• Drive root-cause analysis, CAPA, defect prevention, and continuous improvement using Lean and Six Sigma tools.

Requirements

• BS degree required.
• 8+ years of Quality Engineer experience required.
• Previous experience in an FDA- and ISO-regulated industry required.
• Knowledge of 21 CFR 820, ISO 13485, MDSAP, ISO 14971, and applicable medical device standards.
• Ability to travel 5–10%.

Nice to have

• CQE certification.
• CQA certification.

Culture & Benefits

• Work supports the development and manufacture of specialty medical devices intended to improve patient outcomes.
• Collaboration spans quality engineering, manufacturing engineering, regulatory, suppliers, and production teams.
• Light physical demands.