Quality Engineer

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 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. IDR is subject to certain governmental recordkeeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, we invite employees to voluntarily self-identify their race or ethnicity, gender, and veteran status (if applicable). Submission of this information is voluntary and refusal to provide it will not subject you to any adverse treatment. The information obtained will be kept confidential and may only be used in accordance with the provisions of applicable laws, executive orders, and regulations, including those that require the information to be summarized and reported to the federal government for civil rights enforcement. You may access this form here.