Software Test Technician

Title: Sr Quality Software Engineer
location: Remote Texas, Ability to travel to Austin, TX
Duration: 12 months

Job Summary
Client is seeking a detail-oriented Software Validation and Quality
Sr Engineer experienced in regulated environments, specializing in software quality review, compliance, and audit
readiness, with hands-on capability in validation and testing activities supporting FDA, IEC and ISO standards.
This is an onsite position, 5 days per week in Austin, Texas.
How You'll Create Impact
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.

Skills:
What Makes You Stand Out
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

Education:
Your Background
Minumum 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 environ