Career

Quality Management Specialist (Part–time, f/m/d)

Welcome to BESA:
Your assignment as a QM Specialist at BESA will cover a variety of task areas within our QM
system and product development processes. This not only offers the opportunity to enhance your
knowledge in different areas of QM, but also guarantees interesting as well as challenging tasks.

Your tasks:
• Assuring of compliance with legal standards and guidelines regarding quality management
especially in the field of medical devices
• Expansion as well as further implementation and maintenance of our DIN EN ISO 13485
based quality management system
• Preparation and implementation of quality relevant processes
• Preparation and maintenance of technical documentation
• Preparation and support of internal and external audits
• Support of development of new BESA products by preparation of technical documentation
files and corresponding internal and external templates
• Support of product manager and developer in creating SOUP and OTS documents
• Support of product manager with respect to PMS tasks
• Monitoring of complaints including implementation of corrective and / or preventive measures

Your profile:
• QM specialist with focus on DIN EN ISO 13485, experience with FDA Part 820 is a plus
• Deep knowledge of MDR and MDD and proficient handling of standards and regulations
• Profound knowledge of MS Office and mobile communication media
• Team player with excellent communication skills and intercultural competence
• Proficient English and German language skills

If these tasks are attractive to you, we would be pleased if you would get in touch with us. Please
send your complete application documents online to Michael Kornwebel, Head of QM, e–mail:
mkornwebel@besa.de.

You can download this description here.