Quality Systems Specialist

hace 1 mes

Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

Careers that Make a Difference

We're a leading medical technology company with a legacy of integrity and innovation. Our mission is to improve patient care and make healthcare more accessible and affordable worldwide.

A Day in the Life

  • Develop and maintain quality programs, systems, processes, and procedures to ensure compliance with policies and standards.
  • Provide expertise and guidance on interpreting policies, regulations, and internal regulations to ensure compliance.
  • Work with operating entities to provide process analysis and oversight to enforce requirements and meet regulations.
  • Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors.
  • Prepare reports and documentation, and provide to stakeholders.
  • Coordinate legal requests in support of government investigations or litigations.
  • Ensure quality assurance programs and policies are maintained and modified regularly.
  • Foster uniform standards worldwide and enable best practice sharing to achieve the company's mission globally.

Requirements

  • Fluent in English and German
  • High degree of organization and prioritization skills
  • Ability to work in a fast-paced environment with high attention to detail and follow through
  • Strong relationship building, communication, and interpersonal skills
  • Proactive and good customer service skills
  • Team player
  • Strong critical thinking and analytical skills
  • Strong project management and critical thinking skills

Preferred Qualifications

  • 1 year of experience working with quality systems or related areas
  • Medical Device Industry experience
  • Knowledge with MS office (Outlook, Word, Excel, PowerPoint, etc.)
  • Previous experience supporting quality system audits
  • Strong technical writing and documentation review skills
  • Independent compliance decision maker
  • Good understanding of Medical Device Regulations and the Food and Drugs Acts
  • Technologist degree related to pharmacy

Our Commitment

We're committed to inclusion, diversity, and equity, and we believe that everyone belongs and is valued for who they are. We're dedicated to driving ID&E forward to enhance the well-being of our employees and accelerate innovation that brings our lifesaving technologies to more people worldwide.

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