2935 IT & Software Developer jobs in the US
Validation Engineer - Software QA
$83,200 - 87,360
Experis
San Jacinto Place 7700, Plano
$83,200 - 87,360
Requirements
Must:
- Proven experience in software validation within a regulated industry such as medical devices, pharmaceuticals, biotechnology, aerospace, or automotive.
- Strong understanding of Software Development Life Cycle (SDLC), validation methodologies, and commitment to Quality Management Systems (QMS).
- Familiarity with regulatory standards pertaining to software in regulated settings.
- Exceptional attention to detail and quality of documentation.
- Bachelors degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field, or equivalent education and professional experience.
- At least 5 years of engineering experience with demonstrated use of quality tools and methodologies.
- Ability to manage multiple tasks and work independently.
- Strong analytical, problem-solving, and communication skills.
- Experience collaborating with cross-functional teams.
- Preferred: 5+ years in ownership of non-product software responsibilities.
- Preferred: Comprehensive experience with the design control process in a collaborative environment.
- Preferred: Knowledge of FDA regulations such as 21 CFR 820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485/14971 guidelines, and FDA 21 CFR Part 11.
- Preferred: Advanced skills in data analysis, statistical analysis, and report writing.
Responsibilities
- Lead and execute validation activities for non-product software systems in compliance with industry standards (e.g., GAMP 5, ISO, FDA 21 CFR Part 11, Part 820, EU MDR).
- Develop, review, and approve validation documentation including User Requirements Specifications (USR), Risk Assessments, Validation Plans, Test Protocols, Traceability Matrices, and Validation Reports.
- Ensure software meets compliance standards for electronic records, signatures, data integrity, and cybersecurity.
- Apply Design Verification and Validation methods, participating in the creation and review of protocols, data summaries, and records.
- Assist with the deployment, upgrade, and change control of Quality Management Systems (QMS), Manufacturing Execution Systems (MES), laboratory systems, and other software tools.
- Maintain the validated state through regular reviews, revalidation, and updating documentation.
- Collaborate with Quality Assurance, Operations, and cross-functional teams to establish software requirements, assess risks, and manage Software/System Test Lifecycle (SLC/STLC).
- Participate in risk management processes and in the development or modification of Risk Management Files and FMEAs, applying risk-based approaches consistently.
- Review software design and validation documents for thoroughness and compliance across varying projects.
- Participate in project teams and technical change review boards, coordinating quality decisions among different groups.
- Facilitate project teams effectively, ensuring adherence to processes and procedures for the safe and effective delivery of products.
Description
We are a well-established company seeking a Validation Engineer III to join our dynamic team in Plano, TX. This is a full-time onsite position with a commitment to maintaining high standards in software validation for our Fortune 500 client. We offer a collaborative work environment, where our employees can engage in meaningful projects and benefit from ongoing professional development. This position comes with a competitive pay range of $40/hr to $42/hr, and we value candidates eligible to work without sponsorship.
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You can find QA, Test Engineer salaries in the United States here.
How many QA, Test Engineer jobs are in the United States?
Currently, there are 2935 QA, Test openings. Check also: Selenium jobs, Cypress jobs, Cucumber jobs - all with salary brackets.
Is the US a good place for QA, Test Engineers?
The US is one of the best countries to work as a QA, Test Engineer. It has a vibrant startup community, growing tech hubs and, most important: lots of interesting jobs for people who work in tech.
Which companies are hiring for QA, Test Engineer jobs in the United States?
VenHub, AMERICAN SYSTEMS, Trimlite, Menusifu, Inc., Concordia Group, Peraton, Active Datacomm among others, are currently hiring for QA, Test roles in the United States.
The company with most openings is Lockheed Martin Corporation as they are hiring for 273 different QA, Test Engineer jobs in the United States. They are probably quite committed to find good QA, Test Engineers.
The company with most openings is Lockheed Martin Corporation as they are hiring for 273 different QA, Test Engineer jobs in the United States. They are probably quite committed to find good QA, Test Engineers.