Supplier Quality Engineer II

Abbott • Menlo Park, CA

8d • Onsite

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.

The Structural Heart Business Mission is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. This role is responsible for conducting supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. The individual must be able to handle supplier audit situations and interactions in a tactful, professional, and effective manner.

Requirements

• Bachelor’s degree in Engineering or Technical Field/related degree.
• 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.

Nice To Haves

• Minimum of 5 years related experience in technical or other QA related positions in a regulated industry is preferred.
• ISO lead auditor certification or equivalent is preferred.

Responsibilities

• Develop and execute 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.
• 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.
• Issue SCARs for supplier corrective/preventive action activities through supplier audits and internal issues with supplier product.
• Analyze Supplier information and present supplier metrics to appropriate CAPA boards.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level