Quality Assurance Engineer – Diagnostics

Abbott Laboratories, Limited. Saint Laurent, Québec, Canada; Illinois; On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott Park (Lake Bluff, IL) in Transfusion Medicine, Diagnostics Division is seeking a Quality Professional to analyze quality standards for components, materials, or services and apply testing methodologies to ensure quality. You will participate in design input, risk management, and verification activities to support safe and effective products.

You will contribute to system compliance, review documentation, and collaborate with cross-functional teams to drive continuous improvement in

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 – 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 perform 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.

Education

Bachelor’s degree in Life Science/Engineering or related field

Job description

Abbott Park (Lake Bluff, IL) in Transfusion Medicine, Diagnostics Division is seeking a Quality Professional to analyze quality standards for components, materials, or services and apply testing methodologies to ensure quality. You will participate in design input, risk management, and verification activities to support safe and effective products.

You will contribute to system compliance, review documentation, and collaborate with cross-functional teams to drive continuous improvement in