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    Bio QA Engineer - Lexington, United States - IV IT SOLUTIONS LLC.

    IV IT SOLUTIONS LLC.
    IV IT SOLUTIONS LLC. Lexington, United States

    3 weeks ago

    Default job background
    Description
    5+ years of Quality Management experience in an FDA-regulated environment
    Strong knowledge of FDA Quality System Regulation (QSR) and experience with FDA audits
    Familiarity with EN ISO 13485, ISO 14971, IVDD, and 21CFR Part 820
    Demonstrated success in achieving results and strong leadership skills
    Proficient in reading engineering drawings, technical writing, and data analysis
    Flexibility, effective communication, and a positive attitude
    Responsibilities

    They'll lead by example with a positive mindset, leveraging critical thinking skills to drive successful project execution
    Effective communication is key, as they engage with team members at all levels, adeptly navigating challenges and influencing outcomes
    Responsibilities include compiling and reporting quality metrics, conducting internal audits, and collaborating with teams to implement action plans
    The candidate will troubleshoot process issues, support complaint investigation, and ensure compliance with FDA regulations and quality standards
    Qualifications

    Bachelor's Degree in engineering
    5+ years of Quality Management experience in an FDA-regulated environment
    Strong knowledge of FDA Quality System Regulation (QSR) and experience with FDA audits
    Familiarity with EN ISO 13485, ISO 14971, IVDD, and 21CFR Part 820
    Demonstrated success in achieving results and strong leadership skills
    Proficient in reading engineering drawings, technical writing, and data analysis
    Flexibility, effective communication, and a positive attitude
    Responsibilities

    They'll lead by example with a positive mindset, leveraging critical thinking skills to drive successful project execution
    Effective communication is key, as they engage with team members at all levels, adeptly navigating challenges and influencing outcomes
    Responsibilities include compiling and reporting quality metrics, conducting internal audits, and collaborating with teams to implement action plans
    The candidate will troubleshoot process issues, support complaint investigation, and ensure compliance with FDA regulations and quality standards

    Ideal candidates will thrive in a dynamic, collaborative environment, contributing to a high-paced team with a focus on achieving measurable outcomes.

    They'll lead by example with a positive mindset, leveraging critical thinking skills to drive successful project execution. Effective communication is key, as they engage with team members at all levels, adeptly navigating challenges and... influencing outcomes.

    Responsibilities include compiling and reporting quality metrics, conducting internal audits, and collaborating with teams to implement action plans. The candidate will troubleshoot process issues, support complaint investigation, and ensure compliance with FDA regulations and quality standards.

    Qualifications


    • Bachelor's Degree in engineering.
    • 5+ years of Quality Management experience in an FDA-regulated environment.
    • ASQ or Six Sigma Certification desired.
    • Strong knowledge of FDA Quality System Regulation (QSR) and experience with FDA audits.
    • Familiarity with EN ISO 13485, ISO 14971, IVDD, and 21CFR Part 820.
    • Demonstrated success in achieving results and strong leadership skills.
    • Proficient in reading engineering drawings, technical writing, and data analysis.
    • Flexibility, effective communication, and a positive attitude
    Company information

    At IV IT Solutions, our team of professionals have years of experience in hiring candidates for various industries or companies.

    Each candidate goes through a detailed screening and evaluation process involving a review of applicants' qualifications, experience, verification of credentials, background, and a lot more parameters.

    The complete procedure also includes understanding your specific business requirements, recruiting, shortlisting, and finalizing the right candidates.

    We strive to understand your culture, background, short and long-term goals to help us understand your business so we can find the best fit.

    We start by putting together a recruitment plan tailored for you. Whether you are a start-up, a mid-tier or a large organization, you can count on our best solutions.

    We, at IV IT, understand how important it is to have the right personnel in heavy investment businesses or industries.

    Keeping in mind, we recruit qualified candidates with the rigorous recruitment process to satisfy your business needs.
    Information Technology, Consulting, Software Development, Cybersecurity, Data Management
    Partnership
    Sugarland, Texas

    Company Specialties:
    STAFFING, Non IT Staffing, IT Staffing, Healthcare Professional Staffing, Business Professional Staffing, Account & Financial Staffing, Contract To Hire, and Direct Hire

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