Abbott Sr Professional Quality in Lake Forest, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Job Description Summary
• Individual should have a comprehensive and technical understanding of the Abbott Diagnostic Assays and Instruments.
• Review and implement Supplier Quality Change Notifications.
• Understands and assesses the impact of a change on the safety and efficacy of a device and its respective label.
• Works with Regulatory on country submissions, Technical Support for Specification Changes, Labeling and Safety and Health on label revisions.
• Previous experience with Abbott Laboratories Label Management System (ALMS), Change Requests (ePAS CRs and DPs).
• Attention to detail is vital to providing a thorough review of changes and ensuring compliance to requirements.
Primary Job Function:
Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes; which adds value to the business.
Core Job Responsibilities:
Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes
Project Management for quality-related activities as well as leading projects
Work in international and cross-functional teams
Ensuring compliance to site level policies and procedures, addressing of noncompliant issues within Division and Corporation as appropriate
Ensuring adherence and maintaining the effectiveness of the Quality System
Evaluation of product safety and efficacy and elevation of risk-based issues
Compliant documentation in area of responsibility
Actively leads issue management due to supplier related topics linking to all relevant stakeholders and suppliers
Acts as Subject Matter Expert (SME) for GSCQA organization linking to site leadership and Auditors as required.
Active participant across all areas of the ADD GSCQA organisation ie Ops support, Project, Supplier Change Notification and Supplier Development
Identifies areas for improvement and is familiar with Design Control / Documentation & Change Control
Position Accountability / Scope:
Receives direction and exercises considerable discretion to own work detail. Recommends possible solutions. Ensures compliant documentation; carrying out tasks related to area of responsibility with management oversight.
Decisions may have short and long term impact.
Minimum Education/Experience Required:
Degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience
At least 5 years work experience in Quality or related field
Good, general understanding of the standards and regulatory bodies that regulate our industry
Strong communication skills
Ability to work independently
Experience in the Healthcare industry is preferred
Demonstrates understanding of how their function supports the business.
Demonstrates technical and business competencies that drive results and continuous improvement.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org