Quality engineer Morristown TN - ESR Healthcare

    ESR Healthcare
    ESR Healthcare Morristown, United States

    1 week ago

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    Description
    Quality engineer Morristown TN

    Experience level:
    Mid-senior Experience required: 3 Years Education level: Bachelor's degree Job function:

    Engineering Industry:

    Consumer Goods Compensation:
    $61,000 - $80,000 Total position: 3 Visa sponsorship eligibility: No


    MUST HAVE:

    • Three+ years of engineering experience in a manufacturing environment is required.
    • Experience in an FDA-regulated environment preferred.
    • Must have Process Validation Experience

    JOB SUMMARY:


    This position develops and executes validation protocols (IQ / OQ / PQ) as required for equipment, sanitization/cleaning, facilities, software, and processes.

    This job will also work with customers regarding customer-specific equipment and process validations.


    ESSENTIAL ACCOUNTABILITIES:

    • Facilitate and maintain validation project documentation, including the Site Validation Master Plan.
    • Serve as the database administrator for Infinity QS (Statistical Process Control) software.
    • Provide statistical analysis support for manufacturing, new product development (NPD), trials and validation activities.
    • Develop SOPs relating to validation and risk management.
    • Monitor and prepare Key Performance Indicators (KPIs) for major customers.
    • Conduct quality/engineering studies to support manufacturing operations.
    • Facility Corrective Action / Preventive Action (CAPA) activities to identify and resolve root cause issues through sound investigation and effective problem-solving techniques within the manufacturing plant.
    • Facilitate and train associates on quality topics required for their positions (SPC / CAPA).
    • Coordinate continuous improvement initiatives alongside internal and external (customer or supplier) representatives.
    • Demonstrate commitment to the company's RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.
    • Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associate's essential accountabilities.
    • Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested.

    QUALIFICATION REQUIREMENTS:
    (To perform this job successfully, an individual must be able to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.)


    • Bachelor's degree in Engineering, science or related field is required.
    • Three+ years of engineering experience, preferably in a manufacturing environment is required.
    • Experience in an FDA-regulated environment preferred.
    • Strong self-starter with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross-functional setting.
    • Demonstrated ability to perform technical Non-Conformance Investigations and Root Cause Analyses.
    • Ability to prioritize and handle multiple tasks; ability to meet deadlines in a fast-paced work environment.
    • Ability to have a flexible work schedule to support department projects and coordinate with production and validation schedules.
    • Technical background in nutritional products, laboratory diagnostics, medical devices, pharmaceutical or similar industry.
    Quality engineer Morristown TN

    Experience level:
    Mid-senior Experience required: 3 Years Education level: Bachelor's degree Job function:

    Engineering Industry:

    Consumer Goods Compensation:
    $61,000 - $80,000 Total position: 3 Visa sponsorship eligibility: No


    MUST HAVE:

    • Three+ years of engineering experience in a manufacturing environment is required.
    • Experience in an FDA-regulated environment preferred.
    • Must have Process Validation Experience

    JOB SUMMARY:


    This position develops and executes validation protocols (IQ / OQ / PQ) as required for equipment, sanitization/cleaning, facilities, software, and processes.

    This job will also work with customers regarding customer-specific equipment and process validations.


    ESSENTIAL ACCOUNTABILITIES:

    • Facilitate and maintain validation project documentation, including the Site Validation Master Plan.
    • Serve as the database administrator for Infinity QS (Statistical Process Control) software.
    • Provide statistical analysis support for manufacturing, new product development (NPD), trials and validation activities.
    • Develop SOPs relating to validation and risk management.
    • Monitor and prepare Key Performance Indicators (KPIs) for major customers.
    • Conduct quality/engineering studies to support manufacturing operations.
    • Facility Corrective Action / Preventive Action (CAPA) activities to identify and resolve root cause issues through sound investigation and effective problem-solving techniques within the manufacturing plant.
    • Facilitate and train associates on quality topics required for their positions (SPC / CAPA).
    • Coordinate continuous improvement initiatives alongside internal and external (customer or supplier) representatives.
    • Demonstrate commitment to the company's RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.
    • Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associate's essential accountabilities.
    • Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested.

    QUALIFICATION REQUIREMENTS:
    (To perform this job successfully, an individual must be able to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.)


    • Bachelor's degree in Engineering, science or related field is required.
    • Three+ years of engineering experience, preferably in a manufacturing environment is required.
    • Experience in an FDA-regulated environment preferred.
    • Strong self-starter with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross-functional setting.
    • Demonstrated ability to perform technical Non-Conformance Investigations and Root Cause Analyses.
    • Ability to prioritize and handle multiple tasks; ability to meet deadlines in a fast-paced work environment.
    • Ability to have a flexible work schedule to support department projects and coordinate with production and validation schedules.
    • Technical background in nutritional products, laboratory diagnostics, medical devices, pharmaceutical or similar industry.
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