Quality Assurance Specialist – Medical Devices

Abbott (abbottcareers2 board); Illinois; On-site; USD 55,000 - 67,000; Full time

Benefits offered by this job

HIP PPO medical plan

Excellent retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Park, IL (Transfusion Medicine, Diagnostics Division) is seeking a Quality Professional to analyze quality standards for components and materials. You will apply methodologies to ensure compliance and drive continuous improvement in a fast-paced lab environment.

You will participate in design input, risk management, verification/validation, and documentation activities, ensuring alignment with FDA/QSR/ISO guidelines and 21 CFR Part 11 where applicable.

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.
• Demonstrates 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 & review of design input, risk management, design verification, design validation, and design output/transfer related change activity.
• Risk Management - participate in development and/or modification of Risk Management Files, FMEA's, etc.
• Design Verification/Validation - develop and review Protocols, Data Summaries & Records focused on assay/commodities.
• Documentation - review docs for accuracy, clarity, and compliance; plan and perform assignments with wide degree of difficulty.
• Quality System Compliance - ensure adherence to site policies and report non-compliance.
• Quality Engineering - may participate on project teams and coordinate quality decisions across groups.
• 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.

Education

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

Job description

Abbott Park, IL (Transfusion Medicine, Diagnostics Division) is seeking a Quality Professional to analyze quality standards for components and materials. You will apply methodologies to ensure compliance and drive continuous improvement in a fast-paced lab environment.

You will participate in design input, risk management, verification/validation, and documentation activities, ensuring alignment with FDA/QSR/ISO guidelines and 21 CFR Part 11 where applicable.