Our client, a small start-up medical device firm located in Arlington Heights – Chicago headquartered in Europe, is looking for their first Quality Assurance professional in the US who is able to work on both an operational and tactical level.
- Overall overview and documentation of all quality activities, procedures, processes and responsibilities.
- As the primary owner maintain the Quality Management System in close collaboration the European team.
- Facilitate 510k processes with the FDA.
Qualifications and experience
- 6+ years of experience in Quality Assurance in the medical devices industry.
- Bachelor Degree in sciences related field preferred.
- Working knowledge and experience in FDA regulations & guidelines, GMP, ISO standards.
- Strong communication skills.
- Strong experience on Quality Management System.
Our client offers a professional environment in a growing and ambitious organization with a young, dynamic, international and open culture, there is much attention for the development of staff and opportunities to grow. For the ideal candidate, excellent compensation will be offered. Growth opportunities to step into a larger role will also be available.