Quality Assurance Specialist

hace 3 semanas

Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

About Abbott

Abbott 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 Abbott

At 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 Opportunity

This position works out of our 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)

Key Responsibilities

  • 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.)

Requirements

  • Bachelor ́s Degree 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 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.

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 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.

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