Quality Engineer, Medical Device Software Validation & Compliance

IDR; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation package

Full Benefits; Medical, Vision, Dental

Industry leading organization

Job summary

IDR is seeking a Quality Engineer for a client project in Austin, TX. The role focuses on software validation, compliance, and quality assurance within a regulated medical device environment, touching the full software lifecycle.

You will perform quality reviews, develop validation plans, and participate in risk assessments and audits. Collaboration across teams and strict traceability will be essential to success in this role.

Qualifications

• 4+ years of software validation and quality experience in a regulated environment (medical device preferred).
• 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 traceability.
• Knowledge of regulatory standards including FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11.

Responsibilities

• Perform software quality reviews of requirements, design, and deliverables to ensure compliance with FDA, ISO, and IEC standards.
• Support validation and verification activities, including developing and executing test plans, protocols, and validation reports.
• Participate in risk assessments, design reviews, and audit readiness activities to maintain compliance.
• Collaborate with cross-functional teams to ensure end-to-end traceability and quality assurance throughout project phases.
• Support change management and ensure proper documentation of software modifications.

Skills

Software validation

Regulatory compliance

Risk assessment

Change management

Configuration management

Traceability

Job description

IDR is seeking a Quality Engineer for a client project in Austin, TX. The role focuses on software validation, compliance, and quality assurance within a regulated medical device environment, touching the full software lifecycle.

You will perform quality reviews, develop validation plans, and participate in risk assessments and audits. Collaboration across teams and strict traceability will be essential to success in this role.