Capa Specialist (m/f/d)

You are a co-responsible expert and central contact person for the process of troubleshooting and initiating corrective and preventive actions.

You assist in identifying the causes of errors, implementing corrective measures, and subsequently reviewing their effectiveness.

You will ensure compliance with current normative and legal requirements and assist in the performance of external and internal audits.

You will work across departments with various areas such as RA, R&D, production, and purchasing.

You have a university degree or completed vocational training and have several years of professional experience in medical technology, preferably in the regulatory or quality environment.

You have a good knowledge of the relevant requirements (e.g., DIN EN ISO 13485:2016; MDR 2017/745; MDSAP, etc.).

You already have professional experience in the field of quality assurance or quality management.

You are interested in and enjoy cross-departmental work and are characterized by an independent, structured, responsible, communicative, and goal-oriented way of working.

You have very good written and spoken German and English skills.