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