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    Quality Engineer - Irvine, United States - TalentBurst, an Inc 5000 company

    TalentBurst, an Inc 5000 company
    TalentBurst, an Inc 5000 company Irvine, United States

    3 days ago

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    Description

    Position: Quality Engineer I (Complaint Investigations), Req#: 6086-1

    Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1

    Location: Irvine, CA (100% onsite)

    Duration: 3 Months Contract

    Job Description:

    Education and Experience:

    • Bachelor's degree in engineering, 0 - 4 years of experience related work experience required
    • Proficient with the Microsoft Office suite
    • Experience with medical device complaint investigations (CAPA's, NCR's, and Root-Cause Analysis)
    • Functional, physical, and visual testing of medical device equipment in a laboratory setting
    • Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
    • Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.
    • Preference is for candidates to have some complaint investigation experience/root cause analysis. Another preference is for medical device experience.

    Roles and Responsibilities:

    • Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
    • Perform hands-on device investigation using visual, dimensional, and test equipment to determine the root cause.
    • Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
    • Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determined by the investigation.
    • Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.
    • Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).
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