Manufacturing Quality Assurance Engineer III

Manufacturing Quality Assurance Engineer III at Merit Medical develops and maintains quality systems for medical device product lines. The role encompasses failure investigation, nonconformance disposition, risk analysis, inspection planning, supplier quality management, and continuous quality system improvement.

Responsibilities

• Investigate failures and determine disposition of nonconforming materials and products
• Develop, review and update risk management documentation and failure mode analyses
• Review and approve Engineering Change Notifications for validation and inspection methods
• Monitor supplier performance through data collection, trending and quality audits
• Evaluate nonconformance records to determine root cause and corrective/preventive actions

Requirements

• Bachelor's degree in Chemistry or related field plus five years quality engineering experience
• Knowledge of 21 CFR 820, ISO 13485, ISO 14791, and medical device standards
• Working knowledge of statistical methodologies and quality tools such as lean manufacturing or Six Sigma
• Strong interpersonal and written/verbal communication skills
• Proficiency with spreadsheets, word processing, databases and applicable software
• Ability to work effectively in team environment with conflict resolution capabilities