Job Description

Job Title: Quality Engineer II


Pay Range: $37.00-$42.00


Location: Draper, UT


Schedule: Standard Office Hours


Duration: 6-Month Contract

The Quality Engineer applies engineering principles to ensure product and process compliance with internal and external quality standards. This role focuses on managing CAPA and NCR processes, conducting receiving inspections, and supporting quality system activities to drive continuous improvement and regulatory compliance.

In this role, you will manage and support a variety of quality processes. Key responsibilities include:

• Lead and support Corrective and Preventive Action (CAPA) investigations, including root cause analysis, implementation, and effectiveness verification.
• Review and process Nonconformance Reports (NCRs), coordinate cross-functional resolution efforts, and ensure timely closure.
• Perform inspections of incoming materials and components to verify conformance to specifications and regulatory requirements.
• Maintain inspection records and collaborate with suppliers to resolve quality issues.
• Assist with internal and external audits and maintain documentation to ensure compliance with ISO 13485 and FDA QSR requirements.
• Analyze quality data, prepare reports on trends and metrics, and recommend improvements to enhance product quality and process efficiency.

• Strong analytical, documentation, and problem-solving skills.
• Excellent verbal and written communication abilities.
• Ability to read and interpret engineering drawings, blueprints, and technical documentation.
• Proficiency with quality tools such as FMEA and root cause analysis.
• Experience with quality software systems and inspection tools.
• Team-oriented with strong organizational skills and meticulous attention to detail.

• Bachelor's degree in Engineering required.
• 2-4 years of relevant quality engineering experience.
• Familiarity with CAPA, NCR, receiving inspection, and regulatory compliance standards.
• Experience in medical device or regulated manufacturing environments preferred.

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