Austin, TX, United States
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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