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Production Quality Assurance Specialist

Company: Evergreen Research Inc.
Location: Golden
Posted on: January 16, 2022

Job Description:

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Maintains the controlled equipment and calibration systems.o Ensures timely release of equipment and contributes to content of equipment specificationso Ensures that new equipment to be tracked as an asset is listed correctly in the asset management systemo Ensures that calibration, maintenance, and verification activities are performed and documentedo Reviews calibration reports to ensure completeness and accuracy of the documentationo Initiates equipment-related incident reports
    • Participates in document control processo Understands and complies with quality record requirementso Monitors compliance with quality record requirements in material handling and productiono Distributes controlled copies of production and quality system documents o Makes copies of customer ECOs o Performs filing checks on approved ECOs o Reviews work order packets for completeness before filingo Creates and modifies quality system documentation to meet ongoing continuous improvement efforts of the company
      • Direct involvement in field service activitieso Oversees decontamination of field returns, where necessaryo Coordinates investigation of field service returns and ensures that investigation is properly documentedo Notifies management if findings indicate that an advisory notice may be needed, based on the findingso Works with production staff and service technicians to ensure that client communication on the returns is up to date and accurate
        • Direct involvement in material controlso Inspects incoming material/raw components, in-process assemblies and finished product, according to documented specificationso Understands and correctly uses sampling plans, as neededo Uses proper ESD procedures in handling and storage of ESD sensitive materialso Initiates and investigates reports for nonconforming materials/equipmento Coordinates and documents investigation into the root cause of nonconformitieso Approves disposition of nonconforming materialso Notifies management when findings indicate that an advisory notice may be neededo Approves materials (e.g., clothing and cleaning supplies) to be used in cleanroom

          • Implements ERI hazardous material program.o Reviews MSDS for incoming chemicals used in either production or development and determines whether to label as hazardouso Maintains hazardous chemical inventory and MSDS bookso Correctly handles, marks, and stores hazardous chemicals and wasteso Coordinates disposal of hazardous chemical waste o Assists in completion of spill reports, when needed
            COMPETENCIES/SKILLS:
            • Ability to work independently and efficiently
            • Ability to manage and prioritize multiple responsibilities
            • Excellent communication skills (written and verbal)
            • Good personal computer skills (Microsoft Office)
            • Working knowledge of engineering documentation
            • Working knowledge of MRP systems and inventory control principles
              EDUCATION AND/OR EXPERIENCE:
              • Minimum of Associates degree in scientific or technical discipline--Bachelors preferred
              • Minimum three years of experience in quality assurance, with at least one year in an FDA-regulated industrymedical device experience preferred
                EDUCATION AND/OR EXPERIENCE
                • Minimum of Associates degree in scientific or technical discipline--Bachelors preferred
                • Minimum three years of experience in quality assurance, with at least one year in an FDA-regulated industrymedical device experience preferredby Jobble

Keywords: Evergreen Research Inc., Denver , Production Quality Assurance Specialist, Professions , Golden, Colorado

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