Quality Professional

About the role

This position works out of our Abbott Park (Lake Bluff, IL) location in the Transfusion Medicine, Diagnostics Division. We’re empowering smarter medical and economic decision‑making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. The Quality Professional will analyze quality standards for components, materials, or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.

Responsibilities

• Design/Change Control – Participating in the development & review of all design input, risk management, design verification, design validation, and design output/transfer related design change activity.
• Risk Management – Understands and applies basic Risk Management principles. Participate in the development and/or modification of Risk Management Files, FMEA’s, etc.
• Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records with a focus on assay and commodities.
• Documentation – Reviews documentation for accuracy, clarity, consistency, completeness, and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
• Quality System Compliance – Maintains awareness of standards that regulate our industry. Ensures compliance with site level policies and procedures by promptly reporting non‑compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
• Quality Engineering – May participate on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products. Apply quality principles, analyze quality records, prepare reports, and recommend improvements. Conduct inspection, verification and validation of components or materials used in development processes. Document quality issues and performance measures for management review. May liaise with external vendors.

Requirements

• Bachelor’s degree in Life Science, Engineering, or closely related discipline is