Senior Quality Manager Medical Technology - Focus on Consulting (m/f/d)

Corscience has been developing medical technology systems in Erlangen since 2001. We are all about defibrillation: we design, develop, standardize and individualize defibrillator technology for the layman application as well as for professionals in the rescue service and in the clinic. Over 100 employees contribute to help and save lives every day. We are looking for support for our QM team as SENIOR QUALITY MANAGER MEDIZINTECHNIK (M/W/D) – CONSULTING • unlimited term of contract • from now on • Reach

Ensuring the requirements and further development of the quality management system taking into account the relevant standards and laws (both internal and customer) Responsibility for the holistic QM support of consulting and development projects Advice on regulatory requirements in the field of information security and cyber security Creation and maintenance of technical documentation Responsible for product risk analysis according to ISO 14971 Accompanying internal and external audits (authorities, customers, suppliers) Implementation of employee training to raise employees' awareness of the importance of quality management for the company and our products

Successfully completed studies in medical or electrical engineering or a comparable qualification Multiannual professional experience in quality management, ideally with strong risk management Knowledge of relevant regulatory requirements and requirements (MDR, ISO 13485, 21 CFR 820, ISO) 14971, IEC 62304, IEC 62366, IEC 60601-1) Experience with the approval of products (MDR, international) Practical knowledge in the common quality management methods and procedures (FMEA, 5W, Ishikawa, etc.) Communication strength in German and English Self-employed, structured and targeted working methods combined with high quality standards Presentation and enthusiasm as well as safe occurrence Motivation to play a leading role in the medium term and to develop a team professionally and personally

Very good, collegial working environment – with DuzKultur across all levels Flexible working time models with remote options, good reconciliation of work and family Modern and high-quality work equipment Comprehensive, structured onboarding with sponsorship program Benefits for occupational pensions, benefits in kind 30 days holiday a year as well as on-going Special leave (e.g. on moving) Regular feedback talks and individual training opportunities Health promotion with our cooperation partner i-gb Changing food trucks in front of the door with Corscience discount Bike-friendly location and good ÖPNV connection, JobRad-L