Senior Quality Engineer

Senior Quality Engineer

Location: Austin, TX

Duration: Longe term

This role is heavily focused on equipment and process validation , with limited emphasis on software validation. The position supports new product development (NPD), acquisitions, manufacturing operations, and Risk Management activities within an FDA-regulated environment.

Key Responsibilities

• Lead Quality Engineering activities supporting NPD, tech transfer, and acquisitions
• Develop, execute, and review validation strategies for equipment, processes, and manufacturing systems
• Write, execute, and approve IQ/OQ/PQ validation protocols and reports
• Support facility moves, equipment installation, and process re-qualification activities
• Lead and support equipment qualification for machine shop equipment, CMMs, QC inspection systems, and...