Software Validation Quality Engineer (Medical Device) Noramtec Consultants Americas - 4.1 Austin, TX Job Details Full-time | Contract $41 an hour 16 hours ago Benefits Health insurance Dental insurance 401(k) Vision insurance Qualifications Quality control corrective actions Feature validation testing Computer science GAMP Defect resolution root cause analysis Computer Science Quality control product testing Medical device testing Test Case Documentation (Quality assurance practices) Embedded systems ISO standards IT quality control Configuration management

FDA 21 CFR

Part 11 Mid-level Quality reports Collaboration with product development teams Bachelor's degree Change management for system development Quality risk management Cloud-based systems Quality control documentation Release management Embedded software System validation Requirements analysis Version control systems Compliance documentation Computer Engineering Software documentation Full Job Description Our client is a global leader in musculoskeletal healthcare. They design, manufacture and market orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products. Their products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Alongside some of the world's top healthcare professionals, they help deliver new possibilities to patients. The Technologies Team with our medical device client is seeking a detail-oriented Software Validation Quality 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. 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 environment (medical device preferred)

Pay:

$41.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Work Location:

Hybrid remote in Austin, TX 78744