Quality Systems Specialist

hace 2 semanas

Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo
About the Role

We're seeking a highly skilled Quality Systems Specialist to join our team at Medtronic. As a key member of our quality assurance 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 to assure compliance.
  • Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
  • Prepare reports and/or necessary documentation (ex-Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.
  • Coordinate legal requests in support of government investigations or litigations.
  • Ensure the quality assurance programs and policies are maintained and modified regularly.
  • Foster uniform standards worldwide and enable best practice sharing, thereby contributing to the achievement of company's mission globally.
Requirements
  • Fluent in English and German languages.
  • 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 (based on knowledge of regulations, available relevant information, alternatives, risk).
  • Good understanding of the Medical Device Regulations and the Food and Drugs Acts as pertinent to the position, working knowledge of ISO 13485, and Medtronic policies and procedures.
  • Technologist degree related to pharmacy.
Our Commitment

At Medtronic, we're committed to inclusion, diversity, and equity. We believe that everyone deserves an opportunity to succeed, and we're dedicated to creating a workplace where all employees feel valued, respected, and empowered to contribute their best work. We're proud to be a leader in medical technology and solutions, and we're excited to have you join our team.

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