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    Quality Compliance Specialist - Irvine, United States - Ledgent Technology

    Ledgent Technology
    Ledgent Technology Irvine, United States

    3 weeks ago

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    Description

    Quality Compliance Specialist

    Duration - 1 Year, Contract, W-2

    Location - Onsite in Irvine, CA

    Max Pay - $30 - $36 an hour

    Key Responsibilities:

    Assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; processing 30-50 complaints concurrently.

    Manage customer relationships and expectations during the course of complaint investigation and resolution process

    Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations

    Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered

    Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA

    Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions

    Prepare and submit final customer correspondence

    Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint

    Additional Skills:

    Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment required

    Proven expertise in MS Office Suite, Adobe, and complaint handling software (ETQ preferred) and ability to operate general office machinery

    Excellent written and verbal communication skills and interpersonal relationship skills

    Demonstrated problem-solving, critical thinking, and investigative skills

    Full knowledge and understanding of policies, procedures, and guidelines relevant to quality compliance

    Good knowledge of medical terms and human anatomy

    Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations

    Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing

    Education and Experience:

    Bachelor's Degree or equivalent in related field

    1+ years of experience required

    All qualified applicants will receive consideration for employment without regard torace, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status.We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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