Quality Professional

Abbott Laboratories • Lewes, DE

13d • $68,000 - $136,000 • Onsite

About The Position

This position works out of our Abbott Park (Lake Bluff, IL) location in the Transfusion Medicine, Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
The Quality Professional 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.

Requirements

• 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.
• Demonstrate understanding of how their function supports the business.
• Demonstrates technical and business competencies that drive results and continuous improvement.

Nice To Haves

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

Responsibilities

• Participating in the development & review of all design input, risk management, design verification, design validation, and design output/transfer related design change activity.
• Participate in the development and/or modification of Risk Management Files, FMEA’s, etc.
• Participates in the development, modification and design review of Protocols, Data Summaries & Records with a focus on assay and commodities.
• Reviews documentation for accuracy, clarity, consistency, completeness, and compliance for projects that vary from low to high complexity. Plans and perform assignments with a wide degree of difficulty.
• Maintains awareness of standards that regulate our industry. Ensures compliance with 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.
• May participate 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, 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.
• May liaise with external vendors.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

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