Quality Engineer

By submitting this application, you acknowledge and consent to engage in conversation with a recruiter or virtual recruiter from IDR Inc. and its affiliates, and contracted partners by receiving calls, AI-generated calls, texts, or emails to the contact information provided. This role involves supporting software validation, compliance, and quality assurance activities within a regulated environment, primarily in the medical device industry.

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

By submitting this application, you acknowledge and consent to engage in conversation with a recruiter or virtual recruiter from IDR Inc. and its affiliates, and contracted partners by receiving calls, AI-generated calls, texts, or emails to the contact information provided. Please ensure that the contact information provided is one you are permitted to use and are authorized to receive such messages on. If your contact information changes during the application process, please notify IDR promptly. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can opt-out of receiving communications at any time by saying or replying with “STOP” and "HELP" for help. To view our privacy policy, you may access it here (https://www.idr-inc.com/privacy-policy/).

PandoLogic. Keywords: Quality Control / Quality Assurance Engineer, Location: Austin, TX - 78703