Job Description

Job Title: Quality Assurance Engineer

9 month contract

On-site in Chandler, AZ

Must be able to work on a W2

Job Summary

The Quality Assurance Engineer is responsible for ensuring the consistent quality of medical device products through the development and implementation of process controls, inspection methods, and testing procedures. This role supports product reliability, minimizes defect rates, and drives continuous improvement initiatives across the manufacturing process. The engineer will work independently, applying sound judgment and technical expertise, while collaborating with cross-functional teams and suppliers to resolve quality issues.

Job Responsibilities

• Develop and implement process control, testing, and inspection procedures to ensure product quality.
• Design and install advanced testing equipment to support product validation and quality assurance.
• Conduct product testing and analyze results to maintain quality standards and minimize defects.
• Investigate defective products and analyze quality data to identify trends and recommend corrective actions.
• Collaborate with suppliers to resolve quality issues, implement corrective actions, and support supplier improvement programs.
• Ensure compliance with applicable regulatory standards, including documentation and audit readiness.
• Contribute to process improvement initiatives using quality tools and methodologies (e.g., CAPA, root cause analysis, Six Sigma).

Job Qualifications

• Bachelor’s degree in Engineering, Quality, or a related technical field.
• 2–3 years of experience in quality assurance or quality engineering in a manufacturing environment, preferably in medical devices.
• Solid understanding of quality assurance principles, testing methodologies, and manufacturing processes.
• Experience with quality systems, root cause analysis, and implementation of corrective/preventive actions.
• Strong analytical, problem-solving, and communication skills.
• Familiarity with ISO 13485, FDA regulations, and other relevant industry standards.

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