Quality Professional

Abbott • Chicago, IL

11d • $61,300 - $122,700

About The Position

The Quality Professional works at Abbott Park (Lake Bluff, Illinois) in Abbott’s Transfusion Medicine, Diagnostics Division. The role analyzes quality standards for components, materials, and services, and applies measures, sampling methods, testing methodologies, and other procedures to ensure those standards are met. The position supports the development and delivery of safe and effective products by applying quality principles, reviewing documentation and quality records, and coordinating quality decisions with quality and engineering groups.

Requirements

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

Nice To Haves

• Knowledge of FDA requirements, Quality System Regulations (QSR), the Medical Device Directive, ISO guidelines, and 21 CFR Part 11.

Responsibilities

• Participate in development and review of design inputs, risk management, design verification, design validation, design outputs, and design transfer related to design changes.
• Apply basic risk management principles and participate in developing or modifying Risk Management Files and FMEAs.
• Participate in developing, modifying, and reviewing design verification and validation protocols, data summaries, and records, with a focus on assays and commodities.
• Review project documentation for accuracy, clarity, consistency, completeness, and compliance.
• Maintain awareness of industry standards and ensure compliance with site policies, procedures, the Quality Policy, and quality system procedures; promptly report noncompliance issues to management.
• Participate in project teams and technical review boards as appropriate, coordinate quality decisions across quality and engineering groups, and facilitate project teams in following processes and procedures.
• 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.
• Liaise with external vendors as needed.

Benefits

• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

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