Quality Assurance Professional

hace 4 días


Alajuela, Alajuela, Costa Rica Medtronic A tiempo completo

About Us

Medtronic is a global leader in medical technology and solutions. Our mission is to alleviate pain, restore health, and extend life for millions of people worldwide.

We are a learning culture that values innovation, collaboration, and teamwork. We strive to make a positive impact on the lives of our patients and customers.

A Day in the Life

As a Quality Systems Specialist, you will be responsible for developing and maintaining quality programs that ensure compliance with regulatory requirements and internal policies.

Your key responsibilities will include:

  • Developing and implementing quality management systems processes, including document control, corrective and preventive action, supplier and distributor management, and compliance.
  • Providing expertise and guidance on interpreting policies, regulations, and internal guidelines to ensure compliance.
  • Collaborating with subject matter experts across the globe to implement quality management systems processes.
  • Working with operating entities to provide process analysis oversight and enforce requirements.
  • Supporting audit and inspection preparation, resolution of findings, and liaising with auditing groups and inspectors.
  • Preparing reports and documentation for stakeholders, both internal and external.

Requirements

To be successful in this role, you will need:

  • A bachelor's degree in engineering, quality, or a related field.
  • Minimum 2+ years of relevant experience in quality system specialist roles or equivalent.
  • Excellent communication skills, fluency in English and Spanish (writing and speaking).
  • Strong knowledge of MS Office, Excel, and computer systems.
  • Previous experience leading programs and projects for quality functional groups.
  • Quality management or document control experience.
  • Familiarity with FDA and regulations.
  • Audit and compliance experience.
  • Corrective and preventive action (CAPA) experience.
  • Technical writing experience.

Estimated Salary: $85,000 - $110,000 per year



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