• Supplier Assurance Engineer II

    AbbottMinnetonka, MN 55345

    Job #902400688

  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

    Primary Job Function

    Responsible for conducting supplier audits; qualifying new suppliers; and monitoring the performance of current suppliers. Must be able to handle supplier audit situations and interactions in a tactful; professional and effective manner.

    Core Job Responsibilities

    Responsible for implementing and maintaining the effectiveness of the quality system.

    Supplier Audits

    • Develop and execute to a supplier audit schedule per current requirements. Develop audit plans and associated supplier communications.

    • Approve and monitor Supplier CAPA plans and activities to closure including objective evidence of effectiveness. ISO lead auditor certification or equivalent is preferred.

    Qualify and then monitor supplier performance per current requirements perform activities that will qualify new suppliers and monitor current supplier base to ensure the status of the suppliers is correct.

    • Work with suppliers as needed to ensure their performance is acceptable per site requirements.

    • Work with Design and Development; Manufacturing; Purchasing and IQA when qualifying and monitoring supplier performance.

    CAPA

    • Through the supplier audits and internal issues with supplier product; issue SCARs for supplier corrective/preventive action activities. Analyze Supplier information and present supplier metrics to appropriate CAPA boards.

    Demonstrated writing and communication skills are required for this position. A thorough understanding of the ISO/QSRs and the ability to apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed.

    Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner.

    Knowledge of regulations and standards affecting in vitro diagnostic's device manufacturing.

    Accountability / Scope

    • This person is recognized as an experienced Quality professional with accountability to Suppliers and sites. This person provides services in a professional; complete and compliant manner with minimal supervision. This person's actions define Abbott for the supplier and as such expectations are for the highest level of professional demeanor which includes dress; speech and written communication.

    • Successful performance of a personnel in this position ensures that supplier deficiencies are avoided resulting in product availability for customers; continual operation and profitability of the business.

    Minimum Experience Required:

    Bachelor degree or equivalent experience in technical/scientific area.

    5+ years of related experience in the technical or other QA related positions in a regulated industry is preferred.

    An Equal Opportunity Employer

    Abbot welcomes and encourages diversity in our workforce.

    We provide reasonable accommodation to qualified individuals with disabilities.

    To request accommodation, please call ~~~ or email ~~~

    Updated 05/20/2019

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