Manufacturing Quality Assurance Engineer III
On-site · South Jordan, Utah, United States
Job Summary
Quality Assurance Engineer III at Merit Medical leads complex quality engineering tasks for specific medical device product lines, including failure investigation, disposition of nonconforming materials, risk analysis, defining/refining inspection plans, data collection and trending for key metrics, supplier quality issues, validation data, and maintaining and improving the quality management system. Responsibilities include evaluating engineering variables on standard projects, initiating Engineering Change Notifications, participating in supplier selection and audits, reviewing nonconformance records and determining corrective actions, ensuring containment of nonconforming product, and contributing to regulatory compliance under 21 CFR 820 and ISO standards. The role emphasizes collaboration, problem solving, documentation, and adherence to quality systems in a regulated manufacturing environment, with multiple shifts available.
Required Qualifications
- Bachelor's Degree in Chemistry or related field with five years quality engineering experience
- Strong interpersonal, organizational, and verbal and written communication skills
- Demonstrated working knowledge of 21 CFR 820, ISO 13485, ISO14791, and other medical device standards
- Experience with quality tools and methodologies (statistical methods, lean, Six Sigma)
- Experience with supplier quality audits and CAPA
- Ability to work in a team and manage multiple tasks
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