Specialist Quality Management (m/f/d)

Responsibility of maintaining the conformity of the QM system Responsibility of implementing international requirements for the QM system (e.g. FDA, MDSAP) Planning, implementation and documentation of internal and supplier audits after 13485 Preparation and monitoring of external audits by notified bodies, customers or authorities Responsibility in creating and maintaining an audit plan Working with cross-site projects with QM reference Responsibility in preparing management reviews Responsibility for defining key figures to achieve quality objectives Responsibility for planning and implementing improvement measures (CAPA) for the QM system and audit deviations Support in the maintenance of technical documentation according to MDR Training on QM processes

Successfully completed technical training with a further training to the technician (m/w/d) or successfully completed technical or scientific studies, ideally with medical technology or comparable qualification Ideally, first professional experience in quality/accreditation management in medical technology Good knowledge of QM systems (FDA: 21CFR Part 820, MDR 2017/745, EN ISO 13485) Good knowledge of regulatory standards in medical technology (EN ISO 14971, EN 62304) English fluent High sense of responsibility and a structured and analytical way Audit qualification as internal auditor according to ISO 13485 Experience in the planning, implementation and documentation of internal and supplier audits (process, system and product audits)

Start-up culture, open and creative team Flat hierarchies, collegial atmosphere and quick decision-making Flexible working hours Enrolment programme and appropriate training Cycling leasing Company fitness