Quality Assurance Engineer for Medical Devices

hace 2 meses


Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo
About Abbott Laboratories

As a global healthcare leader, Abbott Laboratories is committed to creating breakthrough science to improve people's health. Our focus on innovation and collaboration enables us to anticipate changes in medical science and technology.

What We Offer
  • Career growth opportunities with an international company where you can develop your skills and advance your career.
  • 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 supportive work environment that allows you to care for yourself and your family, be your true self, and live a full life.
The Opportunity

This position is based out of our Costa Rica - Alajuela location in the Electrophysiology Division. In this role, you will contribute to advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, enabling individuals to restore their health and lead fulfilling lives.

You will work closely with Manufacturing and Engineering teams to ensure compliance with quality system requirements and Key Performance Indicators (KPIs) such as Non-Conforming Material Rates (NCMRs), Manufacturers' Alerts (MAs), Yield, and Cost Reduction projects. Additionally, you will own/lead process/product validation activities, collaborate with Research and Development and Regulatory Affairs personnel to ensure compliance with product and regulatory requirements, and conduct Major Quality System investigations and audits.

Responsibilities
  • Support technical and statistical investigations concerning optimization and compliance to specifications.
  • Develop and maintain quality engineering methodologies and provide quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support.
  • Conduct NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations, and Complaint Investigations (MA) related to manufacturing processes.
Requirements

We are seeking a highly skilled and experienced Quality Assurance Engineer for Medical Devices with a Bachelor's Degree in a STEM field (Science, Technology, Engineering, or Math). You should have at least 5-7 years of experience in Quality Engineering positions, with a strong background in statistical/data analysis and report writing experience. Additionally, you should have experience with control of non-conforming material, corrective and preventive actions, process improvement tools, FDA, GMP, and ISO 13485 regulations.

Our ideal candidate has advanced knowledge of English, excellent communication skills, and experience working in a team environment. If you are passionate about quality assurance and want to make a meaningful impact in the healthcare industry, we encourage you to apply.



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