Senior Quality Engineer
On-site · Austin, Texas, United States
Job Summary
Senior Quality Engineer responsible for developing and maintaining inspection methods and QC systems, supporting and troubleshooting inspection, test, and laboratory equipment (CMMs, X-ray inspection, dye penetrant testing, metallography), and coordinating qualification, calibration, validation, and continuous improvement initiatives. Serves as a technical resource for quality and product verification, leads QA projects for NPD transfers, ensures compliance with GMP/ISO and corporate quality-system requirements, and collaborates with cross-functional teams across receipt, storage, manufacture, and distribution to drive quality and regulatory compliance. Responsibilities include creating and approving validation protocols and documents, leading CAPA investigations, performing internal/supplier quality audits, developing validation/master plans, and ensuring product/process validations meet design input requirements. Requires strong knowledge of metrology, sampling plans, design controls, risk management (FMEA), and a demonstrated ability to lead quality initiatives in a regulated manufacturing environment.
Required Qualifications
- Associate’s or Bachelor’s degree in Engineering, Science, Quality, Manufacturing, Metrology, or a related technical field; equivalent combination of education and relevant experience may be considered
- Experience operating, programming, troubleshooting, or supporting Coordinate Measuring Machines (CMMs) in a manufacturing/quality/metrology/laboratory environment
- Knowledge of GMP, ISO standards, and quality management systems in regulated manufacturing environments (medical device/pharmaceutical/biomedical)
- Familiarity with inspection and test equipment such as X-ray inspection systems, dye penetrant testing equipment, metallography preparation and analysis equipment
- Ability to read and interpret engineering drawings, specifications, procedures, standards, and technical documentation
- Strong analytical, troubleshooting, organizational, and communication skills; ability to work cross-functionally; proficiency with Microsoft Office and related software
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