Internal Auditor - Irvine, United States - Prismatik

    Prismatik
    Prismatik Irvine, United States

    4 weeks ago

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    Description

    Job Description

    Job DescriptionEssential Functions:
    • Understands and follows Prismatik's Quality Manangement System per training.
    • Understands and complies with rules and Company policies.
    • Manages the internal audit lifecycle including but not limited to planning, generating the audit schedule, execution, reporting, managing response, and follow-up on commitments/CAPA.
    • Conducts internal audits and participates in third party audits.
    • Reviews and monitors documentation, as assigned, to ensure compliance with relevant standards, regulations, and guidance documents.
    • Coordinates, liaises, and participates with internal teams to provide guidance on manufacturing processes or quality systems compliance.
    • Stays abreast on relevant domestic and international standards and regulations in order to monitor and ensure conformance.
    • Analyzes all elements of the Quality System and judges their degree of adherence to the criteria for management and control processes.
    • Collects and analyzes data to evaluate department goals and objectives for the internal audit process.
    • Performs verification and effectiveness check of the action items implemented by process owner.
    • Maintains the Internal Audit database.
    • Participates in supplier audit as part of critical supplier selection and evaluation.
    • Interprets recommendations, observations, and findings from the result of the audit to ensure that corrective actions are appropriate and effective.
    • Presents and distributes internal audit reports including action items from internal audit results.
    • Participates in improvement projects for the Quality System, as needed.
    • Performs other related duties and projects as business needs require at direction of management.
    Education and Experience:
    • Bachelor's degree in related field or equivalent experience.
    • Minimum of three (3) years of experience in quality systems within the medical device industry.
    • Minimum four (4) years experience performing GMP/ISO internal audits.
    • Training in Quality Systems including relevant Regulations and Standards.
    Special Requirements/Certification:
    • ASQ Certified Quality Auditor, ASQ Certified Biomedical Auditor, ASQ Certified Medical Device Auditor OR IRCA Certification preferred.

    Pay: $56,659-94,431