German Language Quality Systems Specialist

hace 1 semana

Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo
Quality Systems Specialist - German Language

We are seeking a highly skilled Quality Systems Specialist with fluency in German to join our team at Medtronic. As a key member of our quality team, you will be responsible for ensuring compliance with policies and regulations, and providing expertise in interpreting policies and regulatory requirements.

Key Responsibilities:
  • Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures.
  • Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations.
  • Work directly with operating entities to provide process analyses oversight and 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/or necessary documentation and provide to applicable stakeholders.
  • Coordinate legal requests in support of government investigations or litigations.
  • Ensure the quality assurance programs and policies are maintained and modified regularly.
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 the Medical Device Regulations and the Food and Drugs Acts as pertinent to the position.

We are committed to creating an inclusive and diverse workplace where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. 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.

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