Engineer, Supplier Quality

Abbott•Minnetonka, MN

17d

About The Position

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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: MAIN PURPOSE OF ROLE 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.

Requirements

Education Level Bachelors Degree (± 16 years)
Major/Field of Study In technical/scientific area.
Education Level an equivalent combination of education and work experience
Experience Minimum 5 years
Experience Details Related experience in technical or other QA related positions in a regulated industry is preferred.

Nice To Haves

ISO lead auditor certification or equivalent is preferred.
Experience Details Related experience in technical or other QA related positions in a regulated industry is preferred.

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