Quality Engineer

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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.

#LI-hybrid   IDR is an equal opportunity employer. We provide reasonable accommodations for disabled employees and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, criminal history, or any other protected category under applicable federal, state, or local laws. We consider all qualified applicants, including those with criminal histories, in compliance with applicable Fair Chance laws. To comply with civil rights laws, we invite applicants to voluntarily self-identify their race, ethnicity, gender, and veteran status. This information is confidential, optional, and will not affect your application. You may access this form here. Pursuant to pay transparency laws, salary ranges and benefits will be disclosed where required by law. Compensation is based on factors such as experience, skills, and qualifications. If you require a reasonable accommodation during the application or interview process, please contact Human Resources at hr@idr-inc.com

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