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    SeniorQuality Compliance Specialist - Irvine, United States - JobRialto

    JobRialto
    JobRialto Irvine, United States

    3 weeks ago

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    Description

    Summary:
    The main function of a quality compliance specialist is to assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate

    Key Responsibilities:

    Manage customer relationships and expectations during the course of complaint investigation and resolution processResearch, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigationsIdentify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encounteredEvaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDASummarize 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 correspondenceAssist 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 complaintAdditional Skills:
    Experience working in a medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment requiredProven expertise in MS Office Suite and ability to operate general office machineryExcellent written and verbal communication skills and interpersonal relationship skillsDemonstrated problem-solving, critical thinking, and investigative skillsFull knowledge and understanding of Client policies, procedures, and guidelines relevant to quality complianceGood knowledge of medical terms and human anatomyFull knowledge of Medical Device Reporting regulations, and regulatory reporting regulationsGood knowledge of Good Documentation Practices (GDP) as it relates to complaint filingAbility to manage confidential information with discretionAttention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentWork is performed independently on complex work and reviewed for accuracy and soundnessEducation and Experience:Bachelor's Degree or equivalent in related field5-7 years of experience requiredEducation: Bachelors Degree#J-18808-Ljbffr
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