Quality Manager - Berlin
Our client is a 20+ years established medical device company who are HQ'd in Berlin and are producing high quality instruments and orthopaedic implants for international distribution in over 30 countries. Due to growth, they are now searching for a Quality Manager to join the RA/QM function, reporting directly to the Head of RA/QM.
Main Tasks
- Assist the QMR in the development and maintenance of Company's QMS.
- Support in QMS digitalization project (non-paper-based document management and training management system) by ensuring to maintain compliance with applicable EN ISO 13485 and MDR 2017/745 requirements
- * Overseeing CAPA processes, including documentation and evaluation.
- Managing complaints, including investigations and evaluations.
- Conducting Risk Analysis in accordance with ISO 14971.
- Participation in audits, including internal and supplier.
- Creating and reviewing quality assurance agreements
Experience required:
- Minimum 3-5 years of professional experience by working in a Quality and Regulatory role within a medical device company.
- Working knowledge of DIN EN ISO 13485:2016, MDR 2017/745, EN 14971:2020, EN 60601 is required. 21CFR Part 820 and MDSAP knowledge is a plus.
- Knowledge of CAPA resolution based on 8-D process and several root cause analysis methods.
- Excellent written and verbal command of German (minimum C1/C2) and English language
If you are interested in the role, apply online today, call +44 203 667 8385 or email your CV