Professional Quality

Abbott • Irving, TX

11d • Hybrid

About The Position

This position works out of our Dallas, TX or Lake County locations 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. Professional Quality will conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes, which adds value to the business.

Requirements

• Apprenticeship or bachelor’s degree in Life Science, Engineering, or closely related discipline, or an equivalent combination of education and work experience.
• Minimum 3 years’ work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.

Nice To Haves

• Demonstrate a firm understanding of the software development lifecycle (SDLC).
• Prefer project experience in software testing practices, methodologies and techniques, particularly in testing medical devices and problem reporting is a plus.
• Prefer tool experience with HP Quality Center (ALM), Serena Business Manager, Siemens Teamcenter Product Data Management (APLM), IBM DOORS.
• Prefer knowledge and experience with FDA design controls, IEC 62304, and ISO 14971.
• Demonstrates understanding of how their function supports the business.
• Demonstrates technical and business competencies that drive results and continuous improvement.

Responsibilities

• Contributes to defining and timely achievement of overall project goals. Scope typically limited to one specific QA function.
• Provides compliant solutions to a variety of problems of moderate scope and complexity.
• Interact constructively with employees, managers, and cross-functional peers.
• May lead a project with a limited scope, but usually a contributor on broader projects.
• Provides guidance to other Professionals and Technicians.
• 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.
• Applies basic Risk Management principles to work.
• Participate in the development or modification of Risk management files.
• Investigates complex complaints with management oversight.
• Ensures compliant documentation related to area of responsibility.
• Identifies areas for process improvement.
• Provides supporting information for change including reasons and justifications.
• Coordinates quality decisions between different quality and engineering groups.
• Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g., FMEAs).
• Receives general direction and exercises considerable discretion to own work detail.
• Recommend possible solutions.
• Provides compliant solutions to a variety of complex problems.
• Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.

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