Quality Engineer

Job description

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.

JOB DESCRIPTION:

Primary Job Function:

The Supplier Quality Engineer will be 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 Responsibilities:

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.

Minimum Qualifications:

Bachelor degree or equivalent experience in technical/scientific area. +2 years of related experience in the technical or other QA related positions in a regulated industry is preferred.

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