Senior Quality Engineer for Argon Medical, a global medical device manufacturer. This on-site role is based in Athens, Texas, United States. The Senior Quality Engineer will develop and maintain quality engineering methodologies across new product development, manufacturing, and service support. Responsibilities include Design Controls and Risk Management: lead design control deliverables such as design and development plans, design inputs/outputs, design reviews, traceability matrices, DHF updates, and DMR readiness; own and facilitate ISO 14971 risk management including hazard identification, risk analyses (FMEA, dfMEA/pFMEA), risk controls, and risk benefit rationale; ensure linkage to verification and validation and post-market surveillance signals. Test Methods, Measurement & Data Integrity: develop, validate, and transfer test methods; establish acceptance criteria using statistics; 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 first article inspection for critical components; ensure supplier controls and incoming inspection align with risk; lead line readiness for pilot builds and production events and promote defect prevention. Regulatory & Standards Compliance: ensure compliance with 21 CFR 820, ISO 13485, MDSAP, ISO 14971, and applicable standards including IEC 60601, ISO 10993, ISO 11135/11137, ISO 11607, IEC 62366, and IEC 62304 for software; provide qu

Senior Quality Engineer for Argon Medical, a global medical device manufacturer. This on-site role is based in Athens, Texas, United States. The Senior Quality Engineer will develop and maintain quality engineering methodologies across new product development, manufacturing, and service support. Responsibilities include Design Controls and Risk Management: lead design control deliverables such as design and development plans, design inputs/outputs, design reviews, traceability matrices, DHF updates, and DMR readiness; own and facilitate ISO 14971 risk management including hazard identification, risk analyses (FMEA, dfMEA/pFMEA), risk controls, and risk benefit rationale; ensure linkage to verification and validation and post-market surveillance signals. Test Methods, Measurement & Data Integrity: develop, validate, and transfer test methods; establish acceptance criteria using statistics; 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 first article inspection for critical components; ensure supplier controls and incoming inspection align with risk; lead line readiness for pilot builds and production events and promote defect prevention. Regulatory & Standards Compliance: ensure compliance with 21 CFR 820, ISO 13485, MDSAP, ISO 14971, and applicable standards including IEC 60601, ISO 10993, ISO 11135/11137, ISO 11607, IEC 62366, and IEC 62304 for software; provide qu