Senior Quality Software Engineer

Our Client, a Medical Devices / Healthcare company, is looking for a Senior Quality Software Engineer for their Austin, TX/Remote location.
 
Responsibilities:

• Perform software quality review of requirements, design, and deliverables to ensure compliance with FDA, ISO and IEC 62304 standards.
• Ensure adherence to quality system processes and design control requirements across the software development lifecycle.
• Review and approve requirement specifications, test plans, validation protocols, traceability matrices (RTM), and validation reports.
• Support requirements activities by ensuring clarity, completeness, and testability of software requirements.
• Ensure end-to-end traceability between requirements, risk controls, and verification evidence.
• Participate in risk assessments and ensure proper implementation and verification of risk control measures.
• Participate in design reviews, code reviews, and quality reviews of software deliverables.
• Support change management activities, including impact assessment and documentation of software changes.
• Support validation and verification (V&V) activities by developing and executing test plans, test cases, and validation protocols as needed.
• Perform functional, integration, and system-level testing for embedded software and cloud-based systems to support product quality.
• Prepare and review validation documentation including test plans, protocols, reports, and compliance records.
• Support defect investigations to ensure proper root cause analysis and closure.
• Support audit readiness activities and regulatory inspections (FDA, ISO).
• This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act

• Strong understanding of software verification and validation (V&V) principles, including test coverage and objective evidence.
• Experience with validation deliverables including test plans, validation protocols, execution reports, and RTM.
• Familiarity with risk management processes and participation in risk assessments (ISO 14971).
• Experience with change management processes and impact assessment.
• Familiarity with configuration management practices, including version control and release traceability.
• Experience in design reviews, code reviews, and quality reviews of software systems.
• Knowledge of regulatory standards including FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11.
• Prior experience working with cross-functional teams including R&D, QA, and Regulatory
• Minimum Requirements:
• Bachelor's Degree and 4 years of relevant experience or equivalent experience
• Preferred Experience:
• Bachelor’s degree in computer science, computer engineering, or a related field.
• 4+ years of software validation and quality experience in a regulated environment (medical device preferred)

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities