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Job Description
SW Validation & Quality Systems Specialist Argon Medical Devices Inc - 3.2 Plano, TX Job Details Full-time 17 hours ago Qualifications Task prioritization
Full Job Description Company Overview:
: Argon Medical Devices is a global manufacturer of specialty medical products. 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 compass 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.
Position Overview:
: The Software validation and quality systems Specialist is responsible for the governance, validation, and administration of Argon's regulated enterprise systems, including the electronic Quality Management System (ETQ Reliance), labeling platforms (BarTender), and other GxP-relevant applications. The Software validation and quality systems Specialist is responsible for planning, executing, and maintaining validation activities for software used in regulated environments. This role ensures that software systems are validated in compliance with applicable regulatory requirements and internal quality system procedures. The position requires cross‑functional collaboration with IT, Engineering, Quality, Regulatory Affairs, and external vendors to ensure software systems are fit for intended use throughout their lifecycle What you will do:: Own and execute the software validation lifecycle (CSV), including validation planning, risk assessments, protocol development, test execution, and final reporting Ensure all system changes follow a controlled validation process, including documented impact assessments and approvals Establish and enforce structured release processes across DEV, TEST, and PROD environments Act as system owner for ETQ Reliance (eQMS), including configuration, administration, and ongoing support Partner with Quality to ensure system workflows support compliant processes (CAPA, document control, training, etc.) Manage validation and control of labeling systems, including BarTender and associated printing infrastructure Ensure all label templates and printing processes are validated and tied to approved specifications Support investigation and resolution of labeling-related issues, including root cause analysis and corrective actions Ensure use of qualified equipment and validated processes in regulated environments Define and enforce change control and release management processes for regulated systems Serve as the primary liaison between IT, Quality, and Operations for validation ownership and responsibilities Support internal and external audits by providing validation documentation, traceability, and system evidence Maintain documentation to ensure systems remain in a validated state and inspection-ready Identify and implement improvements to validation processes, system controls, and compliance practices Skills for
Success:
: Bachelor's degree in Engineering, Information Systems, Quality, or related field 5+ years of experience in software validation or quality systems within a regulated industry Hands-on experience with eQMS platforms (ETQ Reliance or equivalent) Experience supporting system validation, including impact assessments, testing, and documentation Experience with labeling systems (BarTender or equivalent) and associated validation requirements Experience working with multiple system environments (Development, Validation/Test, Production Strong understanding of computer system validation (CSV) in regulated environments Working knowledge of CSV/CSA, GxP, FDA 21 CFR Part 11, ISO 13485 , EU GMP Annex 11, ISO 14971 Strong technical, analytical, troubleshooting, and problem-solving skills High attention to detail and documentation discipline Ability to establish structure and governance in ambiguous environments Strong communication and collaboration skills across IT, Quality, and Operations Ability to manage multiple priorities in a fast-paced environment
