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
Requirements:
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)