Quality Assurance Professional
hace 2 meses
**About Abbott Laboratories**
We are a global healthcare leader, creating breakthrough science to improve people's health. Our team is always looking towards the future, anticipating changes in medical science and technology.
**The Opportunity**
This position works out of our global network in the Electrophysiology Division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through groundbreaking medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
As the Quality Engineer, you will be responsible for sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators. You will work closely with Manufacturing and Engineering to own/lead process/product validation activities and support Major Quality System investigations.
**Your Responsibilities**
- Verify company's adherence to the established Quality System and GMP/ISO standards.
- Conduct NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations, and Complaint Investigations related to manufacturing Process.
- Complete and approve document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
- Execute IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications.
**Requirements**
- Bachelor's Degree in Engineering.
- 0-3 years of experience.
- Knowledge of statistical, data analysis.
- Knowledge in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma, Quality Tools.
**Preferred Qualifications**
- Prior medical device industry experience.
- Previous Quality Engineering experience.
- Experience with SAP ERP System.
- Knowledge on product and process qualification and validation.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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