QA Specialist I

Title: QA Specialist II

Location: Abbott Park, Illinois

Duration: 6 Months

WHAT YOU’LL DO

• The Specialist Quality Assurance within Abbott Diagnostics Division will analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.
• Design/Change Control - Responsibilities include 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. Participates 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.
• Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
• Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to 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 – Participates 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, analyzes quality records, prepares reports and recommends improvements.
• Conduct inspection, verification and validation of components or materials used in development processes.
• Document quality issues and performance measures for management review.
• Ideally looking for someone with recent lab experience with Abbott Transfusion Medicine or ADD, but open to others with quality experience.
• Bachelors Degree required with 1-3 years experience / degree in a scientific discipline (biology, biochem, some sort of engineering) would be helpful. (manager will consider new grads) Will be nice to have experience with medical devices

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelor’s Degree Required

Preferred

• Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11 has context menu

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.