Quality Engineer I

Abbott

Alajuela
Permanente
Tiempo completo

Hace 14 días

JOB DESCRIPTION:About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

Career development with an international company where you can grow the career you dream of.
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 OpportunityThis position works out of our Costa Rica – Alajuela location in the Electrophysiology Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.As the Quality Engineer I, you will be responsible to work closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR’s, MA’s, Yield, Cost Reduction projects, etc.) and owns/lead process/product validation activities. Work closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements. Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal)What You’ll Do

Verify company’s adherence to the established Quality System and GMP/ISO standards.
Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
Completion and approval of document Change Requests, assuring 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.
Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)

Required Qualifications

Bachelor´s Degree Engineering.
0-3 years of experience.
Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
Knowledge of statistical, data analysis.
Knowledge in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
Knowledge with control of nonconforming material, corrective and preventive actions.
Knowledge of FDA, GMP, and ISO 13485 regulations.
Intermediate Command of English.
Shift B

Preferred Qualifications

Prior medical device industry experience.
Previous Quality Engineering experience.
Experience with SAP ERP System.
Knowledge on product and process qualification and validation.
1 - 2 years of experience in Quality or Engineering positions.

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.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: EP ElectrophysiologyLOCATION: Costa Rica
Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2ADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: NoMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment

Abbott

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