Job Description:

Location: Irvine, CA

Salary: $34.00 USD Hourly - $34.75 USD Hourly

Description:

Position Title: Quality Engineer I



Duration: Contract



Work Location: Irvine, CA




Job Duties:



Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.

Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness

Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.

Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation

Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization

Proficient in project management, data analysis, root cause analysis, communication, and risk determination

Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.



Must Have Requirements:



Bachelor's degree in Engineering

College Grads (encouraged to apply

Contact: hsharma04@judge.com


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