Italian Quality Systems Specialist

hace 2 semanas

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

Transforming Healthcare with Quality Systems

At Medtronic, we're committed to delivering innovative medical technologies that improve patient care and outcomes. As a Quality Systems Specialist, you'll play a critical role in ensuring our products and services meet the highest standards of quality and compliance.

A Day in the Life

  • Develop and maintain quality programs, systems, processes, and procedures to ensure compliance with policies and regulatory requirements.
  • Provide expertise and guidance on interpreting policies, regulations, and internal guidelines to ensure compliance.
  • Work with operating entities to provide process analyses and oversight to enforce requirements and meet regulations.
  • Lead audit and inspection preparation, resolution of audit and inspection findings, and liaison with auditing groups and inspectors.
  • Prepare reports and documentation, and provide to stakeholders, both internal and external.
  • 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 Italian
  • 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

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