Senior Quality Assurance Engineer II

Senior Quality Assurance Engineer II at Merit Medical in Pearland, TX leads quality management for medical device product lines and processes. The role involves risk documentation, nonconformance review, supplier evaluation, and implementation of quality system improvements within a regulated manufacturing environment.

Responsibilities

• Evaluate and apply engineering techniques and procedures to assigned product lines and processes independently
• Manage risk documentation, failure modes analysis, and process improvement implementation for product lines
• Review and approve Engineering Change Notifications for verification, validation, and inspection methods
• Investigate nonconformance records to determine disposition, root cause, and corrective/preventive actions
• Monitor supplier performance through data collection, trending, and quality audits

Requirements

• Bachelor's degree in engineering or related field plus three years quality engineering experience
• Knowledge of 21 CFR 820, ISO 13485, ISO 14791, and medical device standards
• Working knowledge of statistical methodologies, lean manufacturing, and Six Sigma
• Strong interpersonal, organizational, and written communication skills
• Proficiency with spreadsheets, word processing, database, and applicable software
• Ability to work effectively in team environments through conflict resolution