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    Quality Assurance Specialist - Doral, United States - LanceSoft

    LanceSoft
    LanceSoft Doral, United States

    3 weeks ago

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    Description

    Job Summary:


    The Complaint Quality Assurance Scientist I (CHU) play a pivotal role in ensuring the overall quality and regulatory compliance of customer complaint investigation processes.

    This position involves reviewing, evaluating, and documenting activities and findings as part of our ongoing global quality process.

    The incumbent will follow established procedures to enter and submit complaints, ensure supporting documentation is attached, correctly classify complaints, and assign investigators/reviewers.

    Additionally, they will design and perform complaint investigations, conduct reviews of complaint trending, and escalate product issues to management.

    The CHU will complete various documents as required, represent QA on cross-functional projects, and exercise judgment within defined procedures and practices.


    Key Responsibilities:
    Enter and submit complaints on behalf of field-based personnel
    Ensure supporting documentation is attached to complaints
    Correctly classify complaints and assign investigators/reviewers
    Design and perform complaint investigations into the Chemistry/Immunoassay product line
    Conduct reviews of complaint trending to determine CAPA eligibility
    Escalate product issues to management
    Complete risk assessments, stop ship assessments, and CAPA requests
    Represent QA on development, current business, or product improvement projects
    Communicate and collaborate with other functions such as Field Service, Call center, manufacturing, R&D, and Post Market Surveillance teams
    Utilize data analysis and problem-solving skills to identify and countermeasure common failure issues
    Maintain robust documentation and adhere strictly to approved procedures
    Gain and utilize basic product technical awareness to facilitate informed evaluation of customer complaints records
    Complete all needed records in a timely and accurate manner within Smart Solve (compliant management system (CMS))


    Qualifications:
    Bachelor's degree in a Science or Engineering related discipline
    Minimum 2 years' experience in a laboratory environment or Quality role with previous experience in a CHU environment
    Good knowledge of FDA QSR and ISO 13485 requirements
    Strong troubleshooting skills

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