Quality Engineer for Medical Devices & Compliance

Abbott; United States; On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

FreeU education program

Global employer recognition

Job summary

Abbott Park, IL, USA, is seeking a Quality/Process role in Transfusion Medicine. You will participate in design/change control, risk management, and verification/validation activities to ensure safe, effective products. Responsibilities include documentation reviews and maintaining quality system compliance across projects.

Required: a Bachelor’s in Life Science or Engineering and 3+ years in quality. Experience with FDA/QSR/ISO 21 CFR 11 is preferred.

Qualifications

• Bachelor’s degree in Life Science, Engineering, or closely related discipline.
• At least 3 years of work experience in Quality or related field; advanced degree may reduce requirement.
• Understanding of how function supports the business.

Responsibilities

• Design/change control activities across development and transfer.
• Risk management file development and updates (FMEA, etc.).
• Design verification/validation, protocols, data summaries, and records review.

Skills

Quality engineering

Risk management

Documentation

Education

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

Tools

FDA regulations

QSR

21 CFR 11

Job description

Abbott Park, IL, USA, is seeking a Quality/Process role in Transfusion Medicine. You will participate in design/change control, risk management, and verification/validation activities to ensure safe, effective products. Responsibilities include documentation reviews and maintaining quality system compliance across projects.

Required: a Bachelor’s in Life Science or Engineering and 3+ years in quality. Experience with FDA/QSR/ISO 21 CFR 11 is preferred.