Professional Quality

About the role

This position works out of our Dallas, TX or Lake County locations in the Transfusion Medicine, Diagnostics Division. We empower smarter medical and economic decision-making to help transform the way people manage their health at all stages of life.

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.
• Interacts 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.
• Quality System Compliance - 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.
• Risk Management - Applies basic Risk Management principles to work. Participate in the development or modification of Risk management files.
• Complaint Evaluation - Investigates complex complaints with management oversight. Ensures compliant documentation related to area of responsibility.
• Design Control / Documentation & Change Control - Identifies areas for process improvement. Provides supporting information for change including reasons and justifications.
• Quality Engineering - 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. Ensures compliant documentation, carrying out tasks related to area of responsibility with management oversight.

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.

Qualifications

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

Skills

• Software Development Lifecycle (SDLC)
• Software Testing Practices, Methodologies, and Techniques
• FDA Design Controls
• IEC 62304
• ISO 14971

Benefits

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : https://abbottbenefits.com/

Pay

The base pay for this position is $68,000.00 – $136,000.00. In specific locations, the pay range may vary from the range posted.