Manufacturing Quality Assurance Engineer III

Merit Medical; South Jordan (UT); On-site; USD 90,000 - 120,000; Full time

Job summary

Merit Medical seeks a Manufacturing Quality Assurance Engineer III to develop and maintain quality systems for medical device product lines. You will lead failure investigations, risk analyses, and supplier quality monitoring, enabling continuous quality system improvements.

Responsibilities include evaluating nonconformances, approving changes, and driving CAPAs through data-driven analysis and cross-functional collaboration. A strong background in statistics and quality tools is required.

Qualifications

• Bachelor's degree in Chemistry or related field with 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 a team environment with conflict resolution capabilities.

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

Skills

Quality engineering

Statistical methods

Lean manufacturing

Six Sigma

Communication skills

Teamwork

Documentation

Databases

Excel

Education

Bachelor's degree in Chemistry or related field

Five years quality engineering experience

Tools

Excel

Quality management software

Job description

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