Quality Assurance Engineer - Diagnostics & Med Devices

Abbott; Illinois; On-site; USD 68,000 - 136,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Job summary

Abbott Park (Lake Bluff, IL) based Quality Professional role in Transfusion Medicine, Diagnostics Division, analyzes quality standards for components and materials across testing processes. You will apply sampling, testing methodologies and documentation to ensure compliance with industry standards.

The incumbent drives continuous improvement through risk management, design verification, and cross-functional collaboration, ensuring safe and effective products reach patients.

Qualifications

• Bachelor’s degree in Life Science, Engineering, or closely related discipline.
• Minimum 3 years of work experience in Quality or related field.
• Demonstrate understanding of how their function supports the business.
• Demonstrates technical and business competencies that drive results and continuous improvement.

Responsibilities

• Design/Change Control—participate in development and review of design input, risk management and transfer activities.
• Risk Management—develop or modify Risk Management Files and FMEA’s.
• Design Verification/Validation—participate in protocols, data summaries, records with focus on assay and commodities.
• Documentation—review documentation for accuracy, clarity, consistency and compliance.
• Quality System Compliance—ensure adherence to Quality policies and procedures.
• Quality Engineering—participate on project teams and coordinate quality decisions.
• Apply quality principles, analyze quality records 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.

Education

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

Tools

Quality systems knowledge

Job description

Abbott Park (Lake Bluff, IL) based Quality Professional role in Transfusion Medicine, Diagnostics Division, analyzes quality standards for components and materials across testing processes. You will apply sampling, testing methodologies and documentation to ensure compliance with industry standards.

The incumbent drives continuous improvement through risk management, design verification, and cross-functional collaboration, ensuring safe and effective products reach patients.