Diagnostics Quality Engineer - Design & Compliance

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

Job summary

Abbott Park (Lake Bluff, IL) hosts a Quality Professional role within the Transfusion Medicine Diagnostics Division. You will analyze quality standards for components, materials, or services, applying methods that ensure compliance and quality across development and production processes.

Responsibilities include design/change control, risk management, verification/validation, and documentation reviews to support safe, effective products.

Qualifications

• Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
• At least 3 years' work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
• Demonstrate understanding of how their function supports the business.
• Demonstrates technical and business competencies that drive results and continuous improvement.

Responsibilities

• Design/Change Control activities including design input, risk management, design verification, validation, and change transfer.
• Develop and modify Risk Management Files and FMEA.
• Design Verification/Validation and protocol reviews focusing on assay and commodities.
• Review documentation for accuracy, clarity, and compliance.
• Maintain awareness of quality standards and regulatory requirements.

Skills

Quality

Risk management

Documentation

Education

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

Job description

Abbott Park (Lake Bluff, IL) hosts a Quality Professional role within the Transfusion Medicine Diagnostics Division. You will analyze quality standards for components, materials, or services, applying methods that ensure compliance and quality across development and production processes.

Responsibilities include design/change control, risk management, verification/validation, and documentation reviews to support safe, effective products.