Abbott Senior Global Quality Systems Specialist 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.
Prepare and maintain metrics that are used to monitor performance for global quality systems and/or quality subsystems and/or division processes for example CAPA; Management Review; Field Communication; etc.
Maintain and monitor quality system records (such as exception reports; quality holds; field actions; etc.)
establishing consistency in application. Supports or interfaces with internal and/or external auditors for these quality system records. Active participant in or leads initiatives for continuous process improvements.
Responsible for implementing and maintaining the effectiveness of the quality system.
Summarize/communicate quality metrics that will be used as objective evidence for area performance or
monitoring quality system health.
Communication with internal and external customers to distribute; reconcile; and verify quality records.
Maintenance of auditable quality records and files.
Supports or interfaces with internal and/or external inspections such as FDA; ISO; and AQR.
Identify and approve nonconformances and potential nonconformances in a timely manner; ensure thorough documentation; and aid in the development of comprehensive CAPA strategies to prevent recurrence.
Active participant in or leads projects/initiatives to improve global quality systems and/or quality subsystems and/or division processes.
The above statements are intended to describe the general nature and level of work being performed; other duties may be performed as assigned.
Position Accountability / Scope
The incumbent reports up through the Director of Global Quality Systems. Maintain high standard of quality and compliance of quality system records. Maintain effective working relationships with internal and/or external customers to maintain compliance of quality system records. Lack of detail and oversight may lead to inconsistencies in the application of the process and noncompliance to the quality system.
Bachelor’s Degree: B.S. or B.A. or Certification in Medical Technology or related scientific field (such as MLT).
Minimum of 2 years of Medical Device experience or other FDA regulated industry experience. Minimum of 2 years Abbott experience is preferred. Experience in maintaining quality records/documents is required. Proficient with Microsoft Suite programs is required.
CAPA certification / Trackwise (ABTRAQ) experience is preferred.
Data analysis / Data mining / Data management
Excel / MS Access proficiency
Meticulous attention to detail.
Working knowledge of SAP preferred.
Experience with affiliates and global distribution / logistics preferred.
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