Quality Engineer – Diagnostics & Medical Devices

Abbott Laboratories; Northern (KY); Hybrid; USD 68,000 - 136,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO) next年

Tuition reimbursement

FreeU education benefit

Retirement plan with high employer贡献

Job summary

Abbott Laboratories in the United States is seeking a Quality Professional for the Transfusion Medicine division. You will analyze quality standards for components, materials, or services and apply measures, sampling methods, testing procedures to meet quality requirements.

Responsibilities include risk management, design verification/validation liaison, and ensuring documentation accuracy. Collaboration with cross-functional teams to maintain compliance with FDA, QSR, ISO guidelines.

Qualifications

• Bachelor’s degree in Life Science, Engineering, or closely related discipline is required.
• At least 3 years of work experience in Quality or related field.
• Knowledge of FDA, QSR, ISO guidelines and 21 CFR Part 11 is preferred.

Responsibilities

• Analyze quality standards for components, materials, or services.
• Apply testing methods and procedures to ensure quality standards.
• Review documentation for accuracy and compliance.
• Coordinate quality decisions with cross-functional teams.

Skills

Quality experience

Regulatory knowledge

Documentation skills

Education

Bachelor’s degree in Life Science or Engineering

Job description

Abbott Laboratories in the United States is seeking a Quality Professional for the Transfusion Medicine division. You will analyze quality standards for components, materials, or services and apply measures, sampling methods, testing procedures to meet quality requirements.

Responsibilities include risk management, design verification/validation liaison, and ensuring documentation accuracy. Collaboration with cross-functional teams to maintain compliance with FDA, QSR, ISO guidelines.