Quality Engineer

IDR is seeking a Quality Engineer to join one of our top clients for an opportunity in Austin, TX. This role involves supporting software validation, compliance, and quality assurance activities within a regulated environment, primarily in the medical device industry. The position offers a chance to work on critical quality initiatives and ensure regulatory adherence across the software development lifecycle.
Position Overview for the Quality Engineer:

• 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.

Requirements for the Quality Engineer:

• 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

What\'s in it for you?

• Competitive compensation package
• Full Benefits; Medical, Vision, Dental, and more!
• Opportunity to get in with an industry leading organization.

Why IDR?

• 25+ Years of Proven Industry Experience in 4 major markets
• Employee Stock Ownership Program
• Dedicated Engagement Manager who is committed to you and your success.
• Medical, Dental, Vision, and Life Insurance
• ClearlyRated\'s Best of Staffing Client and Talent Award winner 12 years in a row.

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