Regulatory Compliance Engineer for Medical Devices

hace 14 horas


Alajuela, Alajuela, Costa Rica Abbott Laboratories A tiempo completo

About Abbott Laboratories

As a global leader in healthcare, Abbott is committed to creating breakthrough science that improves people's health.

We are always looking towards the future, anticipating changes in medical science and technology. Our team is dedicated to making a positive impact on people's lives.

The Opportunity

This role will be based in our Costa Rica location, working out of the Structural Heart Division. In this division, we design and provide device and management solutions for the treatment of structural heart disease.

As the Quality Systems and Compliance Engineer I, you will play a crucial role in supporting Quality Systems activities to evaluate compliance to regulatory requirements. You will administer regulatory compliance of the Learning Management System (LMS) under general supervision.

Your Key Responsibilities

  • Create and/or maintain employee learning maps to ensure they are up-to-date with current QMS documents.
  • Manage the LMS audience structure to maintain standards among current and future Value Streams and support areas.
  • In accordance with area managers, oversee appropriate training planning, execution, and documentation for exempt employees.
  • Support internal compliance audits at the Costa Rica facility.
  • Support the coordination of external audits/inspections preparation and support and/or participate during external audits, as required.
  • Facilitate follow-up and closure of audit/assessment nonconformances.
  • Provide support to the Quality Systems team in the maintenance of the Quality Management System elements.

Requirements

  • Bachelor's degree in Industrial Engineering, Administration or related field or having successfully covered at least 85% of the curriculum at the University to obtain Engineering or Business Administration degree and is currently studying.
  • 2 years previous experience in quality or training related areas.
  • Knowledgeable of Quality Management Systems (QSRs, ISO 13485 or ISO 9001).
  • Intermediate commands of English.

Estimated Salary Range: $55,000 - $70,000 per year

Why Choose Abbott?

At Abbott, you can grow your career, learn new skills, and care for yourself and family. We offer diverse opportunities with a company that can help you build your future and live your best life.



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