Software Quality Engineer

About the role

Based in Austin, Texas, reporting to Sushanth Mothukuri.

Responsibilities

• Provide Quality and Validation oversight for software verification and validation activities to ensure compliance with internal procedures, customer requirements, and applicable regulatory standards.
• Ensure software validation policies, procedures, and lifecycle requirements are effectively implemented and maintained from system planning through retirement for non-product software systems supporting medical device manufacturing operations.
• Execute and manage software validation and control activities.
• Author, review, approve, and manage software validation deliverables, including: Validation Plans, User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Test Plans, Protocols, and Reports, Traceability Matrices, Validation Summary Reports, Change and Release Documentation.
• Monitor validation projects and deliverables to ensure adherence to approved methodologies, validation strategies, documentation requirements, and project timelines.
• Assess software changes, incidents, deviations, and nonconformances to determine validation impact and ensure appropriate actions are implemented.
• Partner with cross-functional teams including IT, Engineering, Manufacturing, Quality, and external customers to support software implementation and validation activities.
• Serve as the Quality representative during computerized system deployments, upgrades, maintenance activities, and retirement processes.
• Support customer, internal, and regulatory audits and inspections by providing software validation documentation, evidence, and compliance expertise.
• Review technical issues and quality system processes and recommend improvements to strengthen compliance, efficiency, and effectiveness.
• Drive and maintain software control practices including change management, access management, data integrity, backup/recovery, and periodic review activities.
• Support risk management activities and ensure appropriate mitigation measures are implemented and documented.
• Contribute to the development and continuous improvement of software validation procedures, templates, and best practices.
• Support process validation, equipment qualification, and other validation activities as required to meet business objectives.

Requirements

• Bachelor's degree in engineering, Computer Science, Life Sciences, Quality, or a related technical discipline.
• Minimum 5 years of experience in Computer System Validation (CSV), Software Validation, or Software Quality within a regulated industry.
• Previous experience supporting medical device, pharmaceutical, biotechnology, or other FDA-regulated environments.
• Strong knowledge of FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU Annex 11, ISO 13485, GAMP 5 and Risk-Based Validation Methodologies.
• Thorough understanding of Software Development Life Cycle (SDLC) processes and computerized system validation principles.
• Experience reviewing and approving SDLC documentation and validation deliverables.
• Knowledge of Change Management, Incident Management, Configuration Management, Risk Management, Data Integrity Requirements.
• Experience with Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) systems, Quality Management Systems (QMS), and other manufacturing software platforms.
• Familiarity with cloud-based systems and cybersecurity controls is a plus.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Self-motivated with the ability to work independently and collaborate across cross-functional teams.
• Strong organizational and project management skills.