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    Quality Compliance Specialist - Irvine, United States - Trinus

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    Description

    Job Description

    Summary:

    • The main role of a quality compliance specialist is to assess provided complaint information and determine if it qualifies as a complaint, escalating when needed.

    Key Responsibilities:

    • Manage customer relationships and expectations throughout the complaint investigation and resolution process.
    • Research, gather information, and collaborate with other departments for complaint investigations.
    • Identify issues and lead projects to enhance processes and recommend solutions.
    • Evaluate complaints for Medical Device Reporting and submit reports to FDA.
    • Summarize findings and formulate conclusions based on investigations and relevant materials.
    • Prepare and send customer correspondence regarding complaints.
    • Assist in organizing meetings to address complaint issues and gather technical information for resolution.

    Additional Skills:

    • Experience in medical device, healthcare, or related fields is necessary.
    • Proficiency in MS Office Suite and general office equipment operation.
    • Strong written and verbal communication skills and problem-solving abilities.
    • Understanding of Edwards' policies, medical terminology, and medical reporting regulations.
    • Familiarity with Good Documentation Practices and ability to manage confidential information.
    • Attention to detail and ability to prioritize in a fast-paced environment.

    Education and Experience:

    • Bachelor's Degree or equivalent in a related field.
    • 1+ years of relevant experience required.
    • At Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE/MBE/SBE/SDB firm accredited by WBENC, NMSDC, and SBA.

      Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives.

      At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit.



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