Quality Assurance Specialist
hace 4 días
Abbott is a global healthcare leader that creates breakthrough science to improve people's health. As a company, we're always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn. You'll have access to career development with an international company where you can grow the career you dream of.
Some of the benefits of working at Abbott include:
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our location in the Structural Heart Division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
As the Quality Engineer I, you will be responsible for working closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators. You'll also own/lead process/product validation activities, work closely with Research and Development and Regulatory Affairs personnel, and support Major Quality System investigations and audits.
Responsibilities
Some of your key responsibilities will include:
• Verifying company adherence to the established Quality System and GMP/ISO standards.
• Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations, and Complaint Investigations related to manufacturing Process.
• Completing and approving document Change Requests, ensuring accuracy, adequacy, and compliance to Quality System and product requirements.
• Executing IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with mentorship from higher-level engineering.
• Supporting Major Quality System investigations, such as CAPAs, HHEs, StopShip, etc.
Required Qualifications
The ideal candidate will have a Bachelor's Degree in Engineering or a related field, with 0-3 years of experience. They will also have knowledge of statistical, data analysis, and process improvement tools such as Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools. Additionally, they will have knowledge of FDA, GMP, and ISO 13485 regulations, as well as intermediate command of English.
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