ACM Recruiting is looking for a Quality Manager / Senior Quality Engineer for our client, an innovative medical device company based in Berlin, Germany’s health capital. You will be a part of an international team of engineers and scientists who are developing immunotherapeutic cancer strategies and artificial intelligence systems for organ donor and cord blood recipient matching.
This is a permanent position with a desired start date on 02 January 2023. Some remote is possible.
- Support in setting up and maintaining the quality management system (ISO13485) in the context of medical device product approval (FDA / EMA)
- Collaboration in the recording and creation of quality management relevant processes
- Creation and management of product files for the software medical product
- Communication with all disciplines involved, in the context of creating documentation for the entire quality management pipeline (risk management, usability, software lifecycle)
- Preparation and compilation of documents for product approvals
- You have completed (university of applied sciences) studies in a scientific or technical discipline
- You have hands on knowledge of software development, ideally in connection with the standards ISO13485, ISO 14971, EN 62304, EN 62366-1 and relevant guidelines on cybersecurity
- You have previous experience in the QM area with the above mentioned regulations
- You possess a good knowledge of German and English, both written and spoken
- You are able to thrive in a team and have good communication skills
- Experience in the field of transplant medicine/immunology is an advantage
- Experience with FDA approval processes (510k, De Novo) is a plus
- Varied and challenging activities in a dynamic and growth-oriented biotech software company
- Tasks that promote both individual freedom and responsibility
- Work in an international and multicultural team
- Flat hierarchies and efficient decision-making processes
- Strong team spirit and a very good working atmosphere
- Working with the latest technologies
- Flexible home office model
If this sounds like you, then I would like to speak to you to let you know more about the position and would be interested in receiving your CV and written references. Please apply at the link below.
Michael Roehl, Executive Director / ACM Recruiting