Quality Manager for Medical Devices - Tuscumbia, United States - Infinity Systems

Savannah Johnson

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Savannah Johnson

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Description

As a medical device manufacturer, we develop and produce innovative medical technology in the field of shock wave devices and shock wave systems of the highest precision. Structured work and a collegial atmosphere are our hallmarks. We rely on the personal responsibility and willingness to learn of our employees, modern approaches, and high quality in all areas.

Your tasks

  • Implementation and implementation of requirements according to EN ISO 13485
  • Support, advice, and training of employees in the field of quality management
  • Digital work with the document management system and BPM tool
  • Personal responsibility in CAPA and training management
  • Conducting norm research (regulatory affairs research)
  • Maintenance of the QM manual according to EN ISO 13485
  • Interdisciplinary work in process optimization (process management)
  • Support for internal and external audits

Your profile

  • Completed studies in medical technology or training in the field of quality management or similar
  • Ideally, you have worked for at least 2 years in a medical device company and are familiar with standards (MDR, EN ISO 13485, etc.)
  • Strong commitment and high quality awareness
  • Very good organizational skills
  • Teamwork, persu

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