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Quality Systems Specialist

hace 2 meses

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

Transforming Healthcare through Quality Excellence

We're a pioneering medical technology company dedicated to making a meaningful difference in people's lives. As a Quality Systems Specialist, you'll play a vital role in ensuring the highest standards of quality and compliance across our global operations.

About the Role

  • Develop and maintain quality programs, systems, processes, and procedures to ensure compliance with policies and regulatory requirements.
  • Provide expert guidance on interpreting policies, regulations, and internal guidelines to ensure seamless compliance.
  • Collaborate with operating entities to provide process analysis and oversight, ensuring requirements are met and regulations are enforced.
  • Lead audit and inspection preparation, resolution of findings, and liaison with auditing groups and inspectors.
  • Prepare reports and documentation, including Corrective and Preventative Actions, and share with stakeholders.
  • Coordinate legal requests in support of government investigations or litigations.
  • Maintain and modify quality assurance programs and policies regularly.
  • Foster uniform standards worldwide and facilitate best practice sharing to achieve our 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

Our Commitment

We're committed to creating an inclusive, diverse, and equitable workplace where everyone belongs, is respected, and feels valued. We believe that equity starts beyond our workplace and we must play a role in addressing systemic inequities in our communities to have long-term sustainable impact.